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Nonabsorbable dietary lipid reduces the absorption of dietary PCBs and increases the excretion of previously absorbed stored PCBs. Absorption of all PCB congeners will presumably be interrupted by nonabsorbable lipid; however excretion will be enhanced only for PCBs that have not been metabolized and also for their lipophilic metabolites. Our study with the nonabsorbable lipid, olestra, in a controlled trial in Anniston residents with elevated PCB levels demonstrated that it is possible to enhance removal of PCBs from the body in the clinically meaningful time frame of 1 year. The rate of disappearance of PCBs in participants who ate 15 g/day of olestra was significantly faster than the rate determined during the 5 years prior to intervention. The rate of disappearance was not changed from the pretrial rate in participants who ingested vegetable oil. Consideration of the role of body weight and fat is an important factor in the design of intervention trials of this kind, and the results of this trial suggest that the level of body fat in individuals will influence the rate of removal from the body. Previously reported data from animals and from a case report indicate that weight loss combined with nonabsorbable dietary lipid will maximize removal of PCBs and presumably other stored organochlorine compounds. The design of future intervention trials should include a focus on body fat levels and changes. Future trials should also include the testing of dietary compounds other than olestra that have affinity for PCBs, such as plant-derived polyphenols.

Detox diets are popular dieting strategies that claim to facilitate toxin elimination and weight loss, thereby promoting health and well-being. The present review examines whether detox diets are necessary, what they involve, whether they are effective and whether they present any dangers. Although the detox industry is booming, there is very little clinical evidence to support the use of these diets. A handful of clinical studies have shown that commercial detox diets enhance liver detoxification and eliminate persistent organic pollutants from the body, although these studies are hampered by flawed methodologies and small sample sizes. There is preliminary evidence to suggest that certain foods such as coriander, nori and olestra have detoxification properties, although the majority of these studies have been performed in animals. To the best of our knowledge, no randomised controlled trials have been conducted to assess the effectiveness of commercial detox diets in humans. This is an area that deserves attention so that consumers can be informed of the potential benefits and risks of detox programmes.

Mice were gavaged with either 14C-labeled 2,2′5,5′ tetrachlorobiphenyl; 3,3′,4,4′ tetrachlorobiphenyl; or perfluorooctanoic acid. Absorption of these compounds was determined by assay of feces collected for 48 h after the gavage. Part of the animals received test diets containing olestra during this 48-hour period to determine its effect on absorption of the compounds. Mice that received the diet without olestra during this period were divided into groups that either continued the diet without olestra or changed to a diet containing olestra. These diets were continued for 7 days, and a second 48-hour fecal collection was made to measure the effect of olestra on enterohepatic circulation of the compounds and their metabolites. The animals were sacrificed, and blood, fat, and liver concentrations of 14C were measured. Olestra decreased the absorption of 2,2′,5,5′ tetrachlorobiphenyl. It also reduced tissue and blood concentrations of this compound. Olestra also decreased the absorption of 3,3′,4,4′ tetrachlorobiphenyl, but it did not alter enterohepatic circulation or tissue concentrations. Olestra significantly increased the excretion of perfluorooctanoic acid in the second 48-hour collection, suggesting an effect on enterohepatic circulation. It did not, however, alter tissue concentrations of perfluorooctanoic acid. These data are consistent with previously observed effects of olestra on the absorption and storage of lipophilic compounds. Keywords: Olestra, Polychlorinated biphenyl, PCB, Perfluorooctanoic acid, Rat, Absorption

The aim of these studies was to evaluate the potential of some nutritional approaches to prevent or reduce the body load of organochlorines (OC) in humans. Study 1 compared plasma OC concentrations between vegans and omnivores while study 2 verified if the dietary fat substitute olestra could prevent the increase in OC concentrations that is generally observed in response to a weight-reducing programme. In study 1, nine vegans and fifteen omnivores were recruited and the concentrations of twenty-six OC (β-hexachlorocyclohexane (β-HCH),p,p′-dichlorodiphenyldichloroethane (p,p′-DDE),p,p′-dichlorodiphenyltrichloroethane (p,p′-DDT), hexachlorobenzene, mirex, aldrin, α-chlordane, γ-chlordane, oxychlordane,cis-nonachlor,trans-nonachlor, polychlorinated biphenyl (PCB) nos. 28, 52, 99, 101, 105, 118, 128, 138, 153, 156, 170, 180, 183 and 187, and aroclor 1260) were determined. In study 2, the concentrations of these twenty-six OC were measured before and after weight loss over 3 months in thirty-seven obese men assigned to one of the following treatments: standard group (33 % fat diet;n13), fat-reduced group (25 % fat diet;n14) or fat-substituted group (1/3 of dietary lipids substituted by olestra;n10). In study 1, plasma concentrations of five OC compounds (aroclor 1260 and PCB 99, PCB 138, PCB 153 and PCB 180) were significantly lower in vegans compared with omnivores. In study 2, β-HCH was the only OC which decreased in the fat-substituted group while increasing in the other two groups (P = 0·045). In conclusion, there was a trend toward lesser contamination in vegans than in omnivores, and olestra had a favourable influence on β-HCH but did not prevent plasma hyperconcentration of the other OC during ongoing weight loss.

Background The 1996 Food and Drug Administration approval of the fat substitute olestra (sucrose polyester) called for active postmarketing surveillance because preapproval studies showed that olestra may lower circulating concentrations of fat-soluble nutrients such as vitamins and carotenoids. Objective The objective of the Olestra Post-Marketing Surveillance Study was to examine whether customary consumption of olestra-containing savory snacks was associated with changes in serum fat-soluble vitamin and carotenoid concentrations among free-living persons in geographically and ethnically distinct US cities. Design Adults (n = 2535) and their children aged 12-17 y (n = 272) in Baltimore, Minneapolis, and San Diego attended clinic visits during which data were collected on diet, savory snack consumption, lifestyle, and anthropometric indexes. Blood samples were drawn to assay carotenoids and vitamins A, D, E, and K. Data and blood samples were collected both before and after the nationwide introduction of olestra. General estimating equations were used in multivariate-adjusted models that examined olestra's association with the specified serum nutrients. Results Compared with no intake, the top 2 tertiles of olestra use in adults were associated with circulating carotenoid concentrations that were modestly but significantly lower (4.3% to 22.4%). There were no significant associations of olestra with any serum nutrients among adolescents. Conclusions This active postmarketing surveillance study of a food additive suggests that small decreases in serum fat-soluble nutrients are attributable to olestra use. Although health outcomes were not measured here, it is unlikely that these small changes in nutrient measures would adversely affect health.

The First Law of Thermodynamics provides a framework for understanding the imbalance between energy intake and expenditure that produces obesity, but it does not help understand the role of genetics, the regulation of food intake, the distribution of body fat, the mechanisms by which diets work or the mechanism by which portion control has gotten out of control. In animals, increasing dietary fat increases body fat, and it is unlikely that humans escape this important biological rule. In epidemiological studies, increasing dietary fat is associated with increased prevalence of obesity probably by increasing the intake of energy dense foods. In the National Weight Loss Registry, three things were associated with weight loss: continued monitoring of food intake, lowering dietary fat intake, and increased exercise. The relation of dietary fat is most evident when physical activity is low. The speed of adaptation to dietary fat is increased by exercise. When dietary fat is reduced, weight is lost, but weight loss eventually plateaus. The rate of weight loss during the initial phase is about 1.6 g/day for each 1% decrease in fat intake. When dietary fat is replaced with olestra to reduce fat intake from 33% to 25% in obese men, weight loss continues for about 9 months reaching a maximum of nearly 6% of body weight and a loss of 18% of initial body fat. In the control group with a 25% reduced-fat diet, weight loss stopped after 3 months and was regained over the next 6 months, indicating the difficulty of adhering to a conventional low-fat diet. Thus, dietary fat is an important contributor to obesity in some people.

Dietary studies are often conducted as longitudinal intervention or crossover trials using multiple days of measurement on each subject during each of several measurement periods, and determining the required numbers of days and subjects is important in designing these studies. Linear mixed statistical models were used to derive equations for precision, statistical power and sample size (number of days and number of subjects) and to obtain estimates of between-subject, period-to-period, and day-to-day variation needed to apply the equations. Two cohorts of an on-going exercise intervention study, and a crossover study of Olestra, each with 14 d of measurement/subject per period, were used to obtain estimates of variability for energy and macronutrient intake. Numerical examples illustrate how the equations for calculating the number of days or number of subjects are applied in typical situations, and sample SAS code is given. It was found that between-subject, period-to-period, and day-to-day variation all contributed significantly to the variation in energy and macronutrient intake. The ratio of period-to-period and day-to-day standard deviations controls the trade-off between the number of days and the number of subjects, and this remained relatively stable across studies and energy and macronutrient intake variables. The greatest gains in precision were seen over the first few measurement days. Greater precision and fewer required days were noted in the study (Olestra) that exerted greater control over the subjects and diets during the feeding protocol.

There is considerable controversy regarding the effects of fat substitutes (such as the non-caloric fat substitute, olestra) on Americans' diet and health. This report gives associations of olestra consumption (in savory snacks) with changes in nutrient intake, serum lipid concentrations, and body weight 1 y after these snacks became available nationally in the United States.Participants were 1178 adults recruited from three large U.S. cities. At baseline (before the availability of olestra), participants attended a clinic visit and completed questionnaires (including a food-frequency questionnaire), provided fasting blood samples, and had height and weight measured. The clinic visit was repeated about 1 y later, after the introduction of olestra-containing snacks in the marketplace. Olestra consumption was categorized as "none," "very low" (0 to0.4 g/d), "low" (/=0.4 to2.0 g/d), and "moderate/high" (/=2.0 g/d).Twenty-five percent of participants reported consuming olestra-containing savory snacks in the preceding month, but only 2% were categorized as moderate/high consumers. Men reported nearly twice as much olestra consumption as women (1.22 versus 0.68 g/d, P = 0.01). Among moderate/high olestra consumers, total energy and carbohydrate intakes increased by 209 kcal/d and 37 g/d, compared with decreases of 87 kcal/d and 14 g/d, respectively, among non-consumers (both Ps for trend = 0.01), corresponding to non-significant changes in percentages of energy from carbohydrate and total fat. Olestra consumption was not associated with statistically significant changes in serum lipids or body weight.This study found very modest changes in total diet, but no changes in serum lipids or body weight, associated with consumption of olestra-containing savory snacks. However, the low use of olestra by the study sample limited the ability of this study to detect significant effects.

Objective: There are many health risks involved with the use of weight loss products by normal weight women. The mass media may compound this problem through the promotion of weight loss products and a thin body size. This study tested women’s perceptions of different weight loss product ads to determine if body dysphoria (i.e., an over concern with body size and shape in normal weight people) was associated with risk beliefs, past behaviors, and intention toward using weight loss products. Method: Normal weight women (age range = 18–41 yr), who were classified as either high (n=45) or low (n=43) on a measure of body dysphoria, rated different weight loss products according to their perception of health risks, past behavior, and their intention to consume the products. These products were a dietary fat substitute (olestra), a prescription obesity medication (sibutramine), and an over-the-counter appetite suppressant (phenylpropanolamine). Results: High body dysphoric women reported higher intentions to use the products as well as increased prior use of two of the three weight loss products. High body dysphoric women did not believe that these weight loss products were harmless. They recognized potential health risks associated with using such products, but nonetheless, expressed intention to use these weight loss products at a higher frequency. Also, several variables related to body image were found to effectively discriminate normal weight women at risk for abusing weight loss products. Discussion: This study found that women who do not need to lose weight but have significant body image concerns were willing to use potentially harmful weight loss products despite the knowledge that such products might pose significant health risks. Techniques utilized by advertising regulatory agencies such as warning labels did not have a strong deterrent effect for stated intentions to use the products. Implications of these findings for public health policy issues were discussed.

International audience; There has been renewed interest in vitamin D since numerous recent studies have suggested that besides its well-established roles in bone metabolism and immunity, vitamin D status is inversely associated with the incidence of several diseases, e.g., cancers, cardio-vascular diseases, and neurodegenerative diseases. Surprisingly, there is very little data on factors that affect absorption of this fat-soluble vitamin, although it is acknowledged that dietary vitamin D could help to fight against the sub-deficient vitamin D status that is common in several populations. This review describes the state of the art concerning the fate of vitamin D in the human upper gastrointestinal tract and on the factors assumed to affect its absorption efficiency. The main conclusions are: (i) ergocalciferol (vitamin D-2), the form mostly used in supplements and fortified foods, is apparently absorbed with similar efficiency to cholecalciferol (vitamin D-3, the main dietary form), (ii) 25-hydroxyvitamin D (25OHD), the metabolite produced in the liver, and which can be found in foods, is better absorbed than the nonhydroxy vitamin D forms cholecalciferol and ergocalciferol, (iii) the amount of fat with which vitamin D is ingested does not seem to significantly modify the bioavailability of vitamin D-3, (iv) the food matrix has apparently little effect on vitamin D bioavailability, (v) sucrose polyesters (Olestra) and tetrahydrolipstatin (orlistat) probably diminish vitamin D absorption, and (vi) there is apparently no effect of aging on vitamin D absorption efficiency. We also find that there is insufficient, or even no data on the following factors suspected of affecting vitamin D bioavailability: (i) effect of type and amount of dietary fiber, (ii) effect of vitamin D status, and (iii) effect of genetic variation in proteins involved in its intestinal absorption. In conclusion, further studies are needed to improve our knowledge of factors affecting vitamin D absorption efficiency. Clinical studies with labeled vitamin D, e.g., deuterated or C-13, are needed to accurately and definitively assess the effect of various factors on its bioavailability.

Olestra, çoklu yağ asidi esterleri ve sükrozun birleşmesiyle meydana gelen ve kalori içermeyen sükroz polyesteridir. Düşük yağ içerikli atıştırmalık gıdaların üretiminde kullanılabilecek, Amerikan Gıda ve İlaç Dairesi (FDA) tarafından onaylanmış bir gıda katkı maddesidir. Olestra üzerinde yapılan çalışmalar hakkında pozitif görüşler olsa da negatif görüşler de bulunmaktadır. Olestra ile ilgili hayvanlar ve insanlar üzerinde yapılan sayısız çalışmaların sonucunda, insan vücudunda bulunan mikro ve makro bileşenlerin emilimini engellediği takdirde büyüme, çoğalma ve toksisite ile ilgili olarak olumsuz etkileri olabileceği kanısına varılmıştır. Olestranın çevreden yok edilebilmesi, aktif atık ve topraklardan izole edilmiş aerobik bakteriler ve mantarlar sayesinde olabilmektedir. Olestra is, a sucrose polyester, a non caloric fat substitute, made from sucrose and several fatty acid esters. It has been approved by the FDA as a food additive used in preparing low-fat deep-frying foods such as savory snacks. Available literature on olestra was evaluated that had both positive an negative connotations. Clinical trials in numerous species of animals including humans were conducted to determine if olestra would affect the utilization and absorption of macro- and micronutrients; the effects of olestra on growth, reproduction, or its toxicity were also examined. The roles of olestra as a fat substitute, how it could effect on humans and environmental, and the potential impacts from its use in large amounts were assessed. Olestra can be removed from the environment by aerobic bacteria and fungi which may be isolated from activated sludge and soils. 86

Social and economic factors, such as cost, income, attitudes, availability and convenience have traditionally impacted consumer food choices. Newer determinants of food choice include the effects of legislation, technology and the increase in percentage of meals eaten outside the home (45% today, projected to be 53% by 2010). In this decade, controversial food technologies include irradiation, genetic engineering and and development of non-digestible fat substitutes. With higher frequency of meals eaten outside the home, there is an increase in transfer of decision making from individuals and families to chefs. This study surveyed 115 chefs for their awareness of and willingness to purchase such technically altered foods. Chefs were also queried concerning support for labeling for genetically modified ingredients and foods. Irradiated ground beef and genetically engineered tomatoes had high levels of willingness to purchase; potato chips made with Olestra had the lowest level of willingness to purchase. Chefs supported mandatory labeling of food containing genetically modified ingredients.

BACKGROUND Dietary fat has been implicated as a risk factor for cardiovascular disease and obesity. OBJECTIVE We evaluated the effect on body weight, body fat, lipids, glucose, and insulin of replacing dietary fat with olestra in moderately obese men. DESIGN Forty-five healthy overweight men were randomly assigned to 1 of 3 diets: control diet (33% fat), fat-reduced diet (25% fat), or fat-substituted diet (one-third of dietary fat replaced by olestra to achieve a diet containing 25% metabolizable fat). Body fat was measured by dual-energy X-ray absorptiometry and visceral and subcutaneous abdominal fat by computed tomography. RESULTS Thirty-six men completed the 9-mo study. Body weight and body fat in the fat-substituted group declined by a mean (+/- SEM) of 6.27 +/- 1.66 and 5.85 +/- 1.34 kg, respectively, over 9 mo compared with 3.8 +/- 1.34 and 3.45 +/- 1.0 kg in the control group and 1.79 +/- 0.81 and 1.68 +/- 0.75 kg in the fat-reduced diet group. At 9 mo, the mean difference in body fat between the fat-reduced and fat-substituted groups was -4.19 +/- 1.19 kg (95% CI: -6.57, -1.81), that between the control and fat-substituted groups was -2.55 +/- 1.21 kg (-0.13, -4.97), and that between the control and fat-reduced groups was 1.63 +/- 1.18 kg (3.96, -0.70). The men eating the fat-reduced diet asked for almost no extra foods, in contrast with the significantly higher requests (P < 0.05) from both of the other 2 groups. CONCLUSION Replacement of dietary fat with olestra reduces body weight and total body fat when compared with a 25%-fat diet or a control diet containing 33% fat.

To examine in two separate studies the effects of replacing dietary fat with Olestra on body composition and weight change in healthy young men and women.Ten healthy, lean young men participated in Study One that was a 22-day single blind, within-subject design. After a control diet (40% fat) for eight days Study One subjects received an Olestra-substituted diet (31% metabolizable fat) for 14 days. Study Two was a randomized parallel-arm clinical trial with 15 healthy, lean and overweight young women. These subjects were randomly assigned to receive a control diet (40% fat), an Olestra-containing diet (31% metabolizable fat) or a reduced-fat diet (31% fat) for 10 weeks. All foods were provided to the subjects, and energy intakes were not restricted. The primary endpoint in both studies was change from baseline in body weight. In Study Two, body composition was measured by dual energy x-ray absorptiometry. In both studies, food intake and nutrient compensation were assessed.In Study One fat substitution by Olestra resulted in a significant 1.7 kg weight loss from baseline. In Study Two, change in body weight and body fat from baseline were statistically significant in all groups, but the group with Olestra lost significantly more weight from baseline (-5.0 kg) than the other two groups. In Study One there was partial compensation for the decreased energy intake, while in Study Two, compensation was seen only for those on the reduced-fat diet.Replacement of 1/3 of dietary fat with Olestra in periods of up to 10 weeks results in weight loss in men and women.

Olestra is a fat substitute made from fatty acids esterified to sucrose and can be used in the preparation of virtually any food made with fat. Foods made with olestra retain the mouthfeel, palatability and satiating effects of their full-fat counterparts without providing any digestible energy. Because olestra provides no energy, it has the potential to be a useful tool in weight loss and weight maintenance. Short-term studies of olestra replacement in foods demonstrate that fat replacement leads to a net reduction in fat intake. When excess total energy is available, fat replacement also reduces total energy intake in lean and obese men and women. In longer-term studies in which olestra is incorporated into the daily diet, there is an incomplete compensation for the fat energy replaced by olestra. When overweight men consumed olestra as part of a varied diet over nine months, weight loss continued for the duration of the study, whereas individuals receiving a typical low-fat diet regained most of the initial weight lost. Other studies are underway to examine the usefulness of olestra in long-term weight maintenance following weight loss. Post-marketing surveillance of olestra foods in the United States indicates that substitution of olestra for only 1-2 g of fat d-1 may be sufficient to prevent the average weight gain reported in adults of 0.5-1.0 kg year-1.

Following approval of the fat replacer olestra for use in preparing savory snacks, Procter & Gamble implemented a postmarketing surveillance program to monitor marketplace introduction. Three and one-half percent of all health effects reported by consumers to the surveillance toll-free number were allergy-type symptoms (e.g., rash, itching, edema, hives, dyspnea). Because of these reports, we investigated whether olestra or some component of olestra snacks was a likely allergen in some subset of the population. A single center, randomized, double-blind, placebo-controlled, within-subject crossover food challenge study was conducted to confirm or refute the allergenicity of olestra snacks. Of the 65 subjects who reported symptoms consistent with immediate hypersensitivity to olestra's postmarketing surveillance program, 14 men and women traveled to the Arkansas Children's Hospital Research Institute to participate in this study. Each subject underwent a standard skin prick test at the beginning of the study, to help determine what component, if any, of the olestra product was allergenic. Following the skin prick test, subjects ate in random order, olestra-containing potato chips and regular fat-containing potato chips. The dose of potato chips consumed at each challenge was at least the amount alleged to have caused the symptoms that prompted the consumer to phone the postmarketing surveillance toll-free number. No subject experienced an allergic reaction after consuming the olestra-containing chips. Nor did any subject elicit a positive response to olestra following the skin prick testing. Two subjects had positive reactions consistent with immediate hypersensitivity after consuming the regular-fat, placebo potato chips. The results of this study confirm that olestra is unlikely to have an allergenic potential.

Following U.S. Food and Drug Administration (FDA) approval for the use of olestra, a noncaloric fat substitute (brand name Olean) in food snacks, the manufacturer agreed to provide safety updates on market experience to the FDA. However, guidelines for food product postmarketing surveillance (PMS) are not available and those typically used with medical products were only partly applicable. In modeling the Olean program, we drew from experience with consumer products and incorporated elements typical of medical product PMS. A cooperative effort was established with Olean snack manufacturers and a two-tiered, multidisciplinary approach enlisting Consumer Relations and Medical Affairs personnel was used to maximize use of specialized skills. The result of this effort was implementation of a reliable PMS system which could handle a high volume of reports from consumers while providing pertinent data required for medical interpretation of these reports. Summaries of data for the Olean snack manufacturers and FDA were generated in timely fashion. In addition to collection of the spontaneous reports from consumers, a clinical studies program was undertaken and an independent medical advisory panel was established. Through these, we gained perspective on the spontaneous reports and additional confirmation of the safety of olestra in savory snacks.

Market introduction of savory snacks containing olestra offered an opportunity to evaluate the safety of olestra in a free-living population and thereby compare the outcome to the previously established safety profile determined in clinical trials in which subjects were required to eat predetermined amounts at prescribed intervals. Therefore, a multifaceted postmarketing surveillance program was designed to evaluate consumer experience and safety of olestra in the marketplace. Customer comments were solicited through toll-free telephone numbers. Collected data were evaluated by both internal and external medical experts. About 10% of toll-free telephone calls reported health effects, most of which were gastrointestinal (GI) in nature. Clinical studies were designed and conducted to determine potential GI effects under the range of consumption patterns reported by toll-free calls. Health effects reported were those found commonly in the general population and analyses of the data found no biological reason to conclude that serious or meaningful health effects were the result of olestra consumption.

The aim of this study was to compare the effects of two nondigested, nonabsorbed dietary components on objective and subjective measures of gastrointestinal (GI) function.A placebo-controlled parallel study compared the effects of wheat bran (20 g/day or 40 g/day in cereal), a well-known dietary fiber, with those of olestra (20 g or 40 g/day in potato chips), a nonabsorbed fat, on stool output, stool apparent viscosity (log peak force for extrusion [PF]), stool water content, and GI symptoms. Sixty subjects resided on a metabolic ward for 9 days: 3 days baseline and 6 days treatment.Compared with placebo, consumption of 20 g/day wheat bran for 6 days resulted in a rapid (within 38 h) increase in mean (+/-SE) stool output (placebo, 150 +/- 29 g/day; bran, 246 +/- 35 g/day, p0.05), a directional increase in mean stool water content (placebo, 81.2 +/- 0.8%; bran, 83.9 +/- 0.8%), stool water output (placebo, 159 +/- 54 g/day; bran, 238 +/- 30 g/day), and bowel movement frequency (BM/day) (placebo, 2.2 +/- 0.4; bran, 2.6 +/- 0.4), and no stool-softening effect (placebo log PF, 2.9 +/- 0.1 g; bran log PF, 2.9 +/- 0.1 g). Wheat bran 40 g/day results were not significantly different from wheat bran 20 g/day. Compared with placebo, consumption of olestra 20 g/day and 40 g/day for 6 days showed no significant difference in mean stool output (151 +/- 18 g/day and 204 +/- 28 g/day, respectively), mean BM frequency (1.8 +/- 0.2 BM/day and 2.1 +/- 0.3 BM/day, respectively), and stool water output (138 +/- 13 g/day and 184 +/- 31 g/day, respectively), a significant (p0.05) decrease in stool water content (75.5 +/- 1.7% and 72.6 +/- 2.2%, respectively), and either no effect on stool apparent viscosity (olestra 20 g/day, mean log PF, 3.0 +/- 0.1 g) or a gradual stool-softening effect beginning study day 6 (olestra 40 g/day, log PF, 2.7 +/- 0.1 g). None of the treatment groups showed a significant increase in GI symptoms compared with placebo.Consumption of wheat bran in excess of levels in a typical Western diet significantly increased stool output, but did not soften normal-viscosity stool nor result in an increase in common GI symptoms. The observed plateau effect for wheat bran at 40 g/day suggests a maximal mechanical stimulatory effect. Consumption of olestra in excess of usual snacking conditions did not result in a significant increase in stool output or common GI symptoms. At the highest level tested, olestra resulted in a gradual stool-softening effect after several days of consumption.

Background: Increased consumption of non-digested, non-absorbed substrates, such as dietary fibre, can lead to an increase in colonic transit rate and stool output. The effects of dietary fibre and olestra on the consistency and water content of digesta residue within the large bowel were not known. Aim: The aim of this study was to determine the effects of dietary fibre and olestra on regional dehydration and apparent viscosity of digesta residue throughout the large bowel. Methods: Seventy-eight pigs were fed diet alone (control) or supplemented with 40 g/day or 80 g/day dietary fibre or olestra and sacrificed 24, 48, 96 or 192 h after initiation of dosing. The large bowel was removed, divided into 13 segments, and the digesta residue/stool was analysed for apparent viscosity (peak force for extrusion) and percentage water content. Results: In control animals, digesta residue occurred as a continuum, from liquid in the cecum (87.9% water) to solid in the rectum (71.5% water). The relatively small decrease in percentage water content (16.4%) resulted in a marked increase in mean apparent viscosity (liquid = 87 g peak force; solid=3919 g peak force). Dietary fibre increased the percentage water content of digesta residue throughout the large bowel. In contrast, olestra decreased the percentage water content of digesta residue in the mid and distal large bowel. At 40 g/day, dietary fibre showed a significant (P

Residue from the processing of savory snacks in olestra was incorporated into dried bakery product. These blends were then included in broiler diets at levels of 5, 10, and 15%, based upon determined TMEn values for the various blends. Cohort groups of birds fed conventional corn-soybean meal diets with no bakery products served as the positive control. Male birds of a commercial strain were grown to 49 days and samples of the birds were processed to determine dressing percentage and carcass yield. No adverse effects on live performance or carcass characteristics resulted from feeding the various blends as compared to the positive control group. These results indicate that residue from processing savory snacks in olestra may be incorporated into broiler diets at levels up to 3% with no adverse effects on performance, provided that proper adjustments are made in the metabolizable energy content of the product.

Objective To identify the characteristics of people consuming olestra-containing foods when first introduced at a test-marketing site. Design Data are from the Olestra Postmarketing Surveillance Study (OPMSS). After the introduction of olestra into a large test-marketing site, study participants received 3 follow-up telephone calls, at 3-month intervals, in which they were questioned about their diets during the previous month. Subjects/setting 1,007 adults in Indianapolis, Ind, who participated in a baseline clinic visit (before introduction of olestra into the food market) and completed at least 2 of 3 follow-up telephone calls (after the introduction of olestra into the market). Statistical analyses performed Logistic regression was used to examine associations between olestra consumption and sociodemographic characteristics, health conditions, attitudes toward health and diet, and health-related behaviors. Results Olestra consumption on at least 1 of the follow-up telephone calls was reported by 41.5% of the study sample, and consumption on 2 or more telephone calls was reported by 20.0% of the sample. Factors associated with early adoption of olestra-containing foods included white ethnicity, higher education, overweight, absence of diabetes, attitudes indicative of diet and health concerns (eg, perceptions that there is a strong relationship between diet and disease), and a lower fat intake. Applications/conclusions In spite of the controversy surrounding the introduction of olestra into the food market, persons with attitudes indicative of diet and health concerns were likely to be early adopters of olestra-containing foods. Dietitians and other health care providers should inquire about intake levels of foods with fat substitutes and ensure that these foods are not being consumed in excessive amounts or being consumed instead of nutrient-dense foods that are naturally low in fat. J Am Diet Assoc. 2000; 100: 198–204.

The aim of this study was to determine the effects of olestra and sorbitol consumption on three accepted objective measures of diarrhea (stool output >250 g/day, liquid/watery stools, bowel movement frequency >3/day), and how stool composition influences reports of common gastrointestinal symptoms. A double-blind, placebo-controlled study compared the effects of sorbitol (40 g/day in candy), a poorly absorbed sugar-alcohol with known osmotic effects, with those of olestra (20 or 40 g/day in potato chips), a nonabsorbed fat, on objective measures of stool composition and GI symptoms. Sixty-six subjects resided on a metabolic ward for 12 days: 2 days lead-in, 4 days baseline, 6 days treatment. Sorbitol 40 g/day resulted in loose/liquid stools within 1-3 h of consumption. In contrast, olestra resulted in a dose-responsive stool softening effect after 2-4 days of consumption. Subjects reported "diarrhea" when mean stool apparent viscosity (peak force (PF), g) decreased from a perceived "normal" (mean +/- SE, 1355 +/- 224 g PF; firm stool) to loose (260 +/- 68 g PF) stool. Mean apparent viscosity of stool during treatment: placebo, 1363 +/- 280 g (firm); olestra 20 g/day 743 +/- 65 g (soft); olestra 40 g/day, 563 +/- 105 g (soft); and sorbitol 40 g/day, 249 +/- 53 g (loose). Of the 1098 stool samples collected, 38% (419/1098) were rated by subjects as "diarrhea," yet only 2% of treatment days (all in the sorbitol treatment group) met commonly accepted criteria for a clinical diarrhea. Sorbitol, but not olestra, increased the severity of abdominal cramping, urgency and nausea compared to placebo. Olestra consumption, at levels far in excess of normal snacking conditions, resulted in a gradual stool softening effect after several days of consumption, did not meet any of the three objective measures of diarrhea, and did not increase GI symptoms. Sorbitol consumption, at only 80% of the dose requiring a "laxative effect" information label, resulted in rapid onset loose/liquid stools and a significant increase in abdominal cramping, urgency and nausea. Overall, subjects categorized stool as "diarrhea" when stool decreased from their perceived "normal," but the vast majority of these reports were not associated with clinically significant diarrhea.

We conducted a prospective, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of the moderate consumption of snacks containing olestra on the international normalized ratio (INR) in 40 patients receiving long-term warfarin therapy. Patients continued their warfarin regimen and were assigned to receive 1.5 servings/day (42 g) for 2 weeks of Pringles Original Flavor Fat Free Potato Crisps with Olean (12 g olestra/1.5 servings) or Pringles Original Flavor Potato Crisps (placebo group). Patients' INRs were measured weekly for 2 weeks. Thirty-six patients completed the first week of the trial. After 1 week, the mean change in the INR from baseline increased by 0.02 +/- 0.5 in the olestra group and by 0.17 +/-0.4 in the placebo group (p= 0.327). Ten patients in the olestra group and 12 in the placebo group completed the second week of the study. Mean change in the INR from baseline was similar at week 2, -0.18 +/- 0.38 and 0.09 +/- 0.53 (p=0.193), respectively. Gastrointestinal side effects (diarrhea, gas, bloating) occurred in three patients in the olestra group and five in the placebo group (p=0.3). Moderate consumption of snacks containing olestra did not significantly affect the INR (> 0.3 U) at 1 week in patients receiving long-term anticoagulation with warfarin. It does not appear that moderate consumption of these snacks would affect the INR after 2 weeks, but this must be confirmed in a larger sample with adequate power at 2 weeks.