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The US Food and Drug Administration (FDA) received a petition from a company requesting that FDA issue an authorized health claim for the relationship between psyllium husk and a reduced risk of type 2 diabetes. After an initial assessment of the available scientific evidence, FDA determined that significant scientific agreement was lacking for this substance-disease relationship, whereupon the company agreed to have its petition reviewed as a qualified health claim. This article describes the process FDA used in conducting an evidence-based review of the science underpinning the proposed claim and addresses certain safety issues associated with psyllium husk that FDA considered in its review of the petition. Of the 6 studies from which scientific conclusions could be drawn, as identified through FDA’s review, psyllium husk significantly improved plasma glucose levels and insulin sensitivity in only 1 study. Therefore, FDA’s enforcement discretion letter for this qualified health claim stated: “Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim.”

A structured interview protocol was used to investigate the ability of older adults (n = 89, age ≥ 65 years) to accurately determine whether three common food items were whole grain, and to assess the package information used in their decision process. Cereal and crackers, which were both whole grain products, were correctly identified by 63% and 66% of participants, respectively. Bread (a refined product), was correctly identified by only 19% of participants, while 46% of participants misidentified the bread as being whole grain. The ingredient list was the information most frequently cited in deciding if a food was whole grain, but participants varied in their ability to accurately interpret it. Package information considered nonpertinent (e.g., the Nutrition Facts label) in identifying a whole grain product was used almost as often as the ingredient list. Older adults would benefit from whole grain education programs that focus on accurately interpreting package information.

Purpose. To investigate consumer understanding and usage of serving size (SS) information on Nutrition Facts (NF) labels. Design. We analyzed three data sources: (1) U.S. Food and Drug Administration (FDA) Health and Diet Survey (HDS) 1994 (n = 1945), 1995 (n = 1001), and 2008 (n = 2584); (2) National Health and Nutrition Examination Survey (NHANES) 2005–2006 and 2007–2008 (n = 10,750); and (3) 2011 FDA Nutrition Facts Label Experimental Study (NFLES) (n = 9493). Data from FDA are cross-sectional and we focused on usage and meaning of SS. Setting. United States. Subjects. Adults (18+ years). Measures. Both HDS and NHANES addressed how often participants used SS information and HDS also asked how SS is determined. Both NHANES and NFLES contained similar questions on the meaning of SS but NFLES also included an open-ended response option. Analysis. We included both quantitative and qualitative measures. Questions were analyzed by demographic variables and body mass index with frequencies, cross-tabulations, and χ2 statistics reported. Results. HDS showed that the percentage of consumers who used SS information often or sometimes increased from 54% in 1994 to 64% in 2008. NHANES and NFLES data indicated that a majority of respondents had misinterpreted the meaning of SS. Women and obese individuals were more likely to use SS often or sometimes, but were also more likely to misinterpret the meaning of SS. A small subsample of NFLES participants expressed a distrust of the SS information. Conclusion. There is a widespread misunderstanding about SS, suggesting the need for clearer NF labels or enhanced education efforts.

Eating disorders among young children are not well characterized. Diet and growth data were collected from toddlers (1-3 years old) at the time of diagnosis of infantile anorexia (IA) and up to 1 year after family counseling. Children (n = 62) were underweight (≤ −2 z-score weight-for-age). Boys (n = 34) had a greater ( P = .04) mean (standard error) weight-for-age percentile than girls (n = 28) and less evidence of wasting ( z-score weight-for-length = −1.8 (0.14) vs −2.3 (0.17), respectively; P = .04). After counseling, girls demonstrated better linear growth than boys (4.14 (0.18) vs 3.47 (0.18) cm/6 months, respectively; P < .002). Significant catch-up in length-for-age was observed across genders and diagnoses of 1.4 (2.07) growth percentiles and 0.13 (0.05) z-scores on the normal curve in 6 months ( P = .019). Head circumference correlated with dietary protein ( r = .23, P = .03), calcium ( r = .32, P = .004), and zinc ( r = .36, P = .001). Girls met or exceeded dietary reference intakes for energy, protein, iron, zinc, vitamin A, and calcium, and boys improved intake of these nutrients ( P < .05) but boys with IA fell short of recommended energy intake. Many children with IA reached tolerable upper intake levels for zinc and vitamin A, which warrants concern. These are the first data published on diet and growth among children with IA.

Purpose. To describe the collaborative process between a grocery retailer and a panel of nutrition experts used to develop a nutrition guidance system (Guiding Stars) that evaluates the nutrient profile of all edible products in the supermarket, and to report the results of the food and beverage ratings. Design. A collaboration between a private retailer and members of the scientific community that led to the development of a scoring algorithm used to evaluate the nutritional quality of foods and beverages. Setting/Subjects. Northeast supermarkets (n = 160). Measures. Food and beverage nutrition ratings and distribution of stars across different grocery categories. Analysis. Descriptive statistics for rating distributions were computed. T-tests were conducted to assess differences in mean nutrient values between foods with zero versus three stars or a dichotomized variable representing all foods with one to three stars. Results. All edible grocery items (n = 27,466) were evaluated, with 23.6% earning at least one star. Items receiving at least one star had lower mean levels of sodium, saturated fat, and sugars and higher amounts of fiber than products not earning stars. Conclusion. The Guiding Stars system rates edible products without regard to brand or manufacturer, and provides consumers with a simple tool to quickly identify more nutritious choices while shopping. The low percentage of products qualifying for stars reflects poorly on the food choices available to Americans.

The objective of this study was to determine whether the Army Physical Fitness Test (APFT) causes oxidative stress and evaluate the impact of dietary antioxidant intake, fitness level, and body composition on changes in oxidative stress. Forty-seven overweight subjects were asked to perform an APFT. Creatine kinase (CK), C-reactive protein (CRP), glutathione peroxidase (GPX), and superoxide dismutase (SOD) were measured before, immediately after, and 24 hr postexercise. CK significantly increased immediately postexercise and at 24 hr postexercise. CRP and GPX significantly increased immediately postexercise, whereas SOD did not change significantly. Antioxidant intake, fitness level, and body composition were found to significantly influence changes in CK, GPX, and SOD after exercise. In conclusion, the APFT causes oxidative stress in overweight subjects. The associations between dietary antioxidants, fitness level, and body composition seen with each of the biomarkers provide support for future research in this area.

BackgroundFish consumption has been shown to be inversely associated with CHD, which may be due to n-3 fatty acids. The n-3 fatty acids, EPA and DHA, are naturally found only in marine sources. Dietary intakes of methylmercury from certain fish have been hypothesized to increase the risk of CHD.ObjectiveTo investigate the relationship between 30 d fish frequency consumption (assessed by FFQ), total blood Hg concentrations and risk markers of CHD in women aged 16–49 years participating in the National Health and Nutrition Examination Survey 1999–2002.DesignMultiple linear regression analyses were used to test (i) the relationships between 30 d fish frequency consumption and five CHD risk markers, i.e. HDL cholesterol (HDL-C), LDL cholesterol, total cholesterol, TAG and C-reactive protein (CRP); and (ii) if total blood Hg attenuated any associations between fish consumption and CHD risk markers in non-pregnant, non-diabetic females aged 16–49 years.ResultsTotal 30 d fish frequency consumption was negatively associated with CRP (b = −0·10, 95 % CI −0·19, −0·02, P = 0·015) and positively associated with HDL-C (b = 1·40, 95 % CI 0·31, 2·50, P = 0·014). Adjustment for other risk factors did not significantly attenuate the associations. Despite the collinearity between fish and Hg, there is a protective association between fish intake and CHD risk factors.ConclusionsThe levels of DHA + EPA and other nutrients in fish may be adequate to offset the hypothesized risks of heart disease related to ingesting Hg from fish.

In developing the noncaloric fat replacement olestra, the Procter & Gamble Company (P&G) complied with government and health agency recommendations urging food manufacturers to market more low-fat food products. For example, one of the goals of the Healthy People 2000 report is to increase to at least 5000 brand items the availability of processed food products that are reduced in fat and saturated fat, from a baseline of 2500 reduced fat items in 1986.' This objective has already been met, as 5618 such products are available according to recent data.2 Although reducing dietary fat intake is important, a major disadvantage of olestra is that it may inhibit the availability of compounds in plant-based foods that may help prevent chronic diseases. Because olestra has a lipid-like chemical structure, it can solubilize and interfere with the absorption of fat-soluble vitamins, carotenoids, and other lipophilic substances, including potentially beneficial phytochernicals (nonnutrient, physiologically active components in plants). Numerous epidemiologic studies have demonstrated that diets rich in fruits and vegetables, important sources of carotenoids and phytochemicals, lower the risk of ~ a n c e r . ~ Fruits and vegetables also may provide protection against heart disease and macular degeneration, an age-related disease of the eye. For example, lutein and zeaxanthin, carotenoids abundant in some green lea6 vegetables, are deposited in the macula of the eye, where they protect the eye by inhibiting lipid peroxidation induced by sunlight. Although olestra has been fortified with all of the fat-soluble vitamins, eating olestra at about the same time that fruits and vegetables are consumed decreases the levels of carotenoids available to the body4 However, neither the National Eye Institute nor the National Cancer Institute (NCI), which were consulted by the Food and Drug Administration (FDA) for their opinion on the carotenoid issue, objected to the FDA approval of 01estra.~ NCI suggests that Americans consume a total of at least five servings of fruits and vegetables each day, but surveys show that most Americans fall short of this recommendation. Consequently, many consumers cannot afford the nutrient losses that may occur with olestra.

We studied the effects of a single exercise session on lipid and lipoprotein concentrations and on postheparin plasma lipoprotein lipase (LPLA) and hepatic triglyceride hydrolase activities (HTGLA) in 11 trained (T) and ten untrained (UT) men. Subjects exercised on a bicycle ergometer at 80% of their maximal heart rate for one (UT) or two hours (T). Blood samples were drawn 24 hours before and at ten minutes and 24, 48, and 72 hours after exercise. Values were analyzed before and after adjustment for estimated changes in plasma volume (PV). High density lipoprotein cholesterol (HDL-C) increased 2 ± 4 mg/dL in T (P < 0.05) and 1 ± 2 mg/dL in UT subjects beginning 48 hours after exercise. This increase was magnified by adjusting for the 5% to 8% postexercise expansion of PV. The increase in HDL in the T subjects was produced by increases in the HDL2-C subfraction (+3 ± 4 mg/dL, P < 0.05) whereas HDL3 increased in the UT men (+2 ± 3 mg/dL, P < 0.05). LPLA did not change in either subject group when estimated PV changes were ignored but increased 11% (P < 0.05) at 24 hours after exercise when PV was considered. HTGLA was 11% below baseline in the UT men 24 to 72 hours after exercise (P < 0.05) but showed no change in either subject group after adjustment for PV. These results demonstrate that exercise acutely increases HDL levels by raising the HDL2 subfraction in T and the HDL3 subfraction in UT men. Exercise also acutely increases LPLA, but changes in lipase activities may be obscured by concomitant changes in PV. The magnitude of acute changes in lipid, lipoprotein, and lipase values were insufficient to account for the larger differences in these parameters generally noted between T and UT subjects.

An apparatus for measuring locomotor activity (LA) of rats is described and demonstrated. Conventional cages were modified to tilt in response to animal LA. Cage movements were detected by a piezoelectric crystal transducer, and the amplified signals outputted to electronic digital counters. The activity cages were utilized to investigate the effects of several dietary levels of vitamin B-6 (0, 0.5, 1.0, and 6.0 mg pyridoxine-HCl/kg diet) and two different temperature conditions (23° and 27°) on the LA of post-weanling rats. Throughout most of the 31/2 week study period, animals in the 0 and 0.5 mg groups were less active (p

We sought to determine the optimal dose of heparin for evaluating the activities of lipoprotein lipase (LPLA) and hepatic triglyceride hydrolase (HTGLA) in postheparin plasma. Nine physically active and ten sedentary men (age 30 ± 5 yr, mean ± SD) received 30, 50, 75, and 100 IU/kg of heparin in random order during a 2-week period. Based on all the samples, the average LPLA in the athletes was 43% higher (P < 0.001) and HTGLA was 19% lower than in the untrained subjects (NS). The greatest LPLA was obtained after a heparin dose of 75 IU/kg, but LPLA after the three highest doses were not significantly different. There was also a dose effect on HTGLA (P < 0.001) with greatest activities following doses of 75 and 100 IU/kg. Despite these dose effects, subjects maintained their rank order for both postheparin lipase activities regardless of the heparin dose. The only exception was for LPLA in the sedentary men probably because of lower LPLA and a smaller range of values. We also examined the effect of repeated daily injections of 75 IU/kg heparin on LPLA, HTGLA, and serum lipids. Repeated heparin administration on three consecutive days produced no significant effects on the apparent lipase activities. When all subjects were combined, HDL-cholesterol was increased over time (P < 0.05) due to increases in both the HDL2 (P < 0.05) and HDL3-cholesterol (NS) subfractions. Infusion of heparin or saline on three consecutive days into 18 additional men, however, had no effect on any lipid parameter. We conclude that 75 IU/kg is as effective as 100 IU/kg of heparin for releasing LPLA and HTGLA and that the relative rank for lipase activities among subjects with a wide range of values is not affected by the heparin dose. Repeated heparin injections do not alter postheparin plasma lipase activities or lipid and lipoprotein concentrations measured on subsequent days.

We examined the effects of high-carbohydrate and high-fat diets on the serum lipid levels of distance runners. For seven days before each study, subjects consumed a diet containing 15% protein, 32% fat, and 53% carbohydrate. During 14-day experimental periods, a control group (n = 10) continued the same diet while two other groups consumed 69% of their calories as either carbohydrate (n = 13) or fat (n = 14). High-density lipoprotein (HDL)-cholesterol decreased 9% during the high-carbohydrate diet because of a 26% fall in the HDL2 fraction (1.063 to 1.125 g/mL). These changes were not accompanied by changes in the levels of apolipoproteins (apo) A-I or A-II. Total and low-density lipoprotein (LDL)-cholesterol initially decreased but subsequently exceeded pre-diet values while triglyceride concentrations increased 30% to 50%. Postheparin lipoprotein lipase activity (LPLA) fell 20%. Despite these dietary effects, HDL and HDL2 cholesterol concentrations in the athletes remained above values typical of sedentary men. The high-fat diet produced different effects on the serum lipids and lipoprotein levels of the athletes. HDL levels changed little during the study although HDL-cholesterol and apo A-I on the last diet day were both slightly above initial values. The high-fat diet provided 111 g of saturated fat per day but had surprisingly little effect on total and LDL-cholesterol whereas serum triglycerides fell by 10% to 20%. Postheparin LPLA increased 30% with fat feeding and the changes in LPLA correlated with alterations in triglyceride levels (r = -0.53, P less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

We used antisera to human A and C apolipoproteins to identify homologues of these proteins among the high-density lipoprotein apoproteins of Macaca fascicularis (cynomolgus) monkeys, and NH2-terminal analysis was used to verify the homology. The NH2-terminal sequence of the M. fascicularis apoA-I is identical with that of another Old World species, Erythrocebus patas, and differs from human apoA-I at only 4 of the first 24 residues. M. fascicularis apoA-II contains a serine for cysteine replacement at position 6 and is therefore monomeric like the apoA-II from all species below apes. Human and monkey apoA-II are not otherwise different through their first 25 residues. About 20% of M. fascicularis apoC-I aligns with human apoC-I through residue 22, and 80% lacks an NH2-terminal dipeptide. Otherwise, the monkey apoC-I differs from the human protein at only 2 of 25 positions. Two forms of M. fascicularis apoC-II were identified. ApoC-II1 is highly homologous with human apoC-II, whereas an NH2-terminal hexapeptide is absent from apoC-II2. ApoC-II2 was the predominant species, and apoC-II1 appears to represent a propeptide from which a hexapeptide prosegment is cleaved at a Gln-Asp bond. Both forms of monkey apoC-II are potent activators of lipoprotein lipase. There are two polymorphic forms of M. fascicularis apoC-III, and their electrophoretic mobilities become identical after treatment with neuraminidase. Except for a glycine for serine substitution at position 10, the first 15 NH2-terminal residues of M. fascicularis and human apoC-III are the same.

We examined possible determinants of serum high density lipoprotein cholesterol (HDL-C) concentrations in 56 male distance runners (aged 20-56 years) by comparing runners whose HDL-C were either above or below the group median of 63 +/- 13 (+/- SD) mg/dl. HDL-C averaged 53 +/- 7 mg/dl for runners below and 73 +/- 11 mg/dl for runners above the median. Neither exercise training (miles run per week, years of running), physical characteristics (height, weight, adiposity), or dietary factors (total daily caloric intake and daily caloric intake from protein, fat, saturated fat, polyunsaturated fat, carbohydrate, and alcohol) differed between the two groups (P greater than 0.05, MANOVA). Apo A-I (P less than 0.01) was higher and triglyceride concentrations lower (P = 0.07) in the high HDL-C group. The data were also analyzed by comparing runners in the lowest and highest tertiles for HDL-C values and essentially the same results were obtained. When all runners were combined, neither training, physical characteristics nor dietary intake was significantly related to HDL-C (P greater than 0.05). Total cholesterol and apo A-I were directly related (r = 0.35 and r = 0.66, respectively, P less than 0.01) and triglycerides inversely related (r = -0.31, P less than 0.05) to HDL-C. Plasma post-heparin lipoprotein lipase activity (LPLA), hepatic triglyceride lipase activity (HTGLA), and HDL-C subfractions were measured in 22 runners.(ABSTRACT TRUNCATED AT 250 WORDS)

We quantified serum lipids and postheparin plasma lipolytic activities in 5 weightlifters presently self-administering androgenic steroids (users) and an equal number not currently using these drugs (non-users). Mean (+/- SD) age (23 +/- 2 vs 25 +/- 4 yr), body weight (102.7 +/- 11.4 vs 86.8 +/- 13.6 kg), and percent body fat (8.6 +/- 2.5 vs 7.8 +/- 6.0%) were not different in users and non-users, respectively. Similarly, there were no differences in total cholesterol (183 +/- 27 vs 176 +/- 32 mg.dl-1) low-density lipoprotein-cholesterol (138 +/- 25 vs 108 +/- 32 mg.dl-1), or triglyceride (93 +/- 26 vs 93 +/- 41 mg.dl-1) levels in the two groups. High-density lipoprotein (HDL)-cholesterol concentrations, however, were significantly lower in the users (26 +/- 10 vs 50 +/- 13 mg.dl-1; P less than 0.05), and most of the difference was due to lower HDL2-cholesterol concentrations (6 +/- 4 vs 22 +/- 9 mg.dl-1; P less than 0.05). Postheparin plasma lipoprotein lipase activity was only slightly lower in the users (3.49 +/- 2.23 vs 5.36 +/- 1.73 mumol FFA.ml-hr-1; P= NS). but hepatic triglyceride lipase activity was significantly higher in this group (27.99 +/- 6.89 vs 11.15 +/- 2.76, mumol FFA.ml-hr-1: P less than 0.001) and correlated inversely with HDL2-cholesterol concentrations (r = -0.81; P less than 0.01). We conclude that androgenic hormones reduce HDL-cholesterol concentrations and the HDL2-cholesterol subfraction, possibly by enhancing hepatic triglyceride lipase activity.

We studied ten male distance runners before and after a marathon to determine the effects of prolonged exercise on serum lipoprotein values and the capacity to clear plasma triglycerides. Serum lipid and lipoprotein concentrations, intravenous fat clearance, and postheparin plasma lipolytic activities were measured 24 hours before and 18 hours after the race. The clearance rate of exogenous fat increased 76% ±64% postheparin lipoprotein lipase activity increased 46% ±35% and fasting triglyceride levels decreased 26% ±13% after the race. High-density lipoprotein (HDL) cholesterol level increased 10%±8% primarily due to a 19%± 17% increase in the HDL 2 subfraction. Changes in the clearance rate of exogenous fat were directly related to changes in HDL cholesterol level and the HDL2 subfraction. Thus, the rise in HDL cholesterol concentrations after prolonged exercise may be a consequence of enhanced fat clearance. ( JAMA 1986;256:2552-2555)

We studied the high-density lipoprotein (HDL) metabolism of five trained men who ran 16 km daily and five inactive men. Runners were leaner and their aerobic exercise capacity was much greater. The mean HDL cholesterol level was 65 mg mg/dL in the runners and 41 mg /dL in the controls. The lipid-rich HDL2species accounted for a much higher proportion of the HDL in runners (49%v29%). Tracer studies of radioiodinated autologous HDL demonstrated that runners did not produce more HDL protein but rather catabolized less. The mean biologic half-life of HDL proteins was 6.2 days in the runners compared with 3.8 days in the sedentary men. The activity of lipoprotein lipase was 80% higher in the postheparin plasma of the runners, whereas the activity of hepatic triglyceride hydrolase was 38% lower. Thus, the prolonged survival of plasma HDL proteins in runners may result from augmented lipid transfer to HDL by lipoprotein lipase or diminished HDL clearance by hepatic lipase. (JAMA1984;252:1034-1037)