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Audrey Giocanti-Aurégan,1 Alfredo García-Layana,2 Tunde Peto,3 Brittany Gentile,4 Gloria C Chi,4 Mirela Mirt,5 Charlotte E Kosmas,6 Jeremy Lambert,7 Sally Lanar,7 Hannah B Lewis,6 Nancy M Holekamp8 1Ophthalmology Department, Avicenne Hospital, Bobigny, France; 2Clínica Universidad de Navarra, University of Navarra, Pamplona, 31009, Spain; 3Queen’s University Belfast, Belfast, UK; 4Genentech, South San Francisco, CA, USA; 5F. Hoffmann-La Roche, Basel, Switzerland; 6Patient Centred Outcomes, ICON Plc, Reading, UK; 7Patient Centred Outcomes, ICON Plc, Lyon, France; 8Pepose Vision Institute, Chesterfield, MO, USACorrespondence: Audrey Giocanti-Aurégan, Ophthalmology Department, Avicenne hospital, 125 Rue de Stalingrad, Bobigny Cedex, 93009, France, Tel +33 14 895 5815, Fax +33 14 895 5212, Email audrey.giocanti@aphp.frPurpose: Neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) patients treated with intravitreally injected anti-vascular endothelial growth factor (anti-VEGF) monotherapies achieve lower vision improvements compared with patients in clinical trials. This qualitative research study aimed to better understand the real-world anti-VEGF treatment experience from nAMD and DME patients’, caregivers’, and retina specialists’ perspectives.Methods: One-time, semi-structured, individual interviews were conducted with adult patients with nAMD or DME treated with anti-VEGF injections for ≥ 12 months, their caregivers, and experienced retina specialists. Interview transcripts were analyzed qualitatively using a thematic analysis approach.Results: A total of 49 nAMD and 46 DME patients, 47 nAMD and 33 DME caregivers, and 62 retina specialists were interviewed in the USA, Canada, France, Germany, Italy and Spain. Most (79%) patients and caregivers reported disruptions to their routine on the day before, the day of, or the day after anti-VEGF injection. Seven nAMD patients (14%) and 14 DME patients (30%) reported having missed an injection visit. The most frequently reported driver for adherence for patients was the doctor–patient relationship (n=66, 70%), whereas for caregivers, it was the ease of booking an appointment (n=25, 32%). Retina specialists reported patient education on the treatment (n=28, 45%) as the most important driver. Treatment barriers could be grouped into four categories: tolerability, clinical factors, logistical parameters and human factors. The most frequently reported barrier to adherence for patients and caregivers was related to side effects (pain/discomfort/irritation: n=63, 67% of patients; n=52, 66% of caregivers), whereas for retina specialists it was logistical parameters (travel logistics: n=44, 71%).Conclusion: This study highlights the importance of the doctor–patient relationship and patient education as key drivers, and treatment tolerability and logistics as key barriers to treatment adherence. Improved doctor–patient relationship/communication and patient education together with new therapies offering convenience, long-acting effectiveness, and better tolerability may improve treatment adherence.Keywords: qualitative interviews, treatment experience, adherence, neovascular age-related macular degeneration, diabetic macular edema

Neha Durgam,1 Triza Brion,1 Hannah B Lewis,1 Biba Tinga,2 Wilson Sanon,3 Mark Lundie,4 Chantal Cadieux4 1ICON Plc, Raleigh, NC, USA; 2Sickle Cell Disease Association of Canada (SCDAC), Toronto, ON, Canada; 3Association d’Anémie Falciforme du Québec, Montreal, Quebec, Canada; 4Pfizer Canada ULC, Kirkland, Quebec, CanadaCorrespondence: Neha Durgam, 4130 Parklake Ave, Suite 400, Raleigh, NC, 27612, USA, Tel +1 267 827 7447, Email Neha.Durgam@iconplc.com; nehadurgam@gmail.comPurpose: There is little research on care-seeking preferences during active pain crises for sickle cell disease (SCD) patients and their caregivers. The objective of this study was to identify relevant, patient or caregiver narratives of the pain crisis experience, to understand the factors that contribute to care-seeking during a pain crisis, and to identify preferences when making care-seeking decisions during a pain crisis.Patients and Methods: Qualitative semi-structured interviews were conducted with Canadian residents with a self-reported SCD diagnosis, who were either ≥ 18 years of age or an adolescent between the ages of 12– 18. Interviews were hosted virtually, audio-recorded, and transcribed verbatim.Results: A total of 23 individuals participated (74% female; 26% male), including six adolescents with parent dyads and 11 adults. Almost all (N = 21, 91.3%) participants were Black/African American. Participants mentioned many factors that influenced care-seeking decisions, mainly the symptom and pain experience; institutional factors (waiting time, the presence of and adherence to treatment guidelines, and the empathy or racial bias felt from medical staff); and subject-level factors (age and a flexibility in daily responsibilities).Conclusion: This study identified important institutional and subject-level considerations involved in care-seeking decisions. Most importantly, this study highlights the racial stigma faced by many patients when care-seeking in the ER and the lack of care protocol implemented, which hinders care-seeking in a dedicated medical facility. From the patient perspective, these are clear gaps to fill to encourage patients to seek and receive the care they deserve.Keywords: vaso-occlusive crisis, sickle cell disease, pain crisis, care-seeking, standard of care

Background An objective of the phase 3 HELP Study was to investigate the effect of lanadelumab on health‐related quality of life (HRQoL) in patients with hereditary angioedema (HAE). Methods Patients with HAE‐1/2 received either lanadelumab 150 mg every 4 weeks (q4wks; n = 28), 300 mg q4wks (n = 29), 300 mg every 2 weeks (q2wks; n = 27), or placebo (n = 41) for 26 weeks (days 0–182). The Angioedema Quality of Life Questionnaire (AE‐QoL) was administered monthly, consisting of four domain (functioning, fatigue/mood, fears/shame, nutrition) and total scores. The generic EQ‐5D‐5L questionnaire was administered on days 0, 98, and 182. Comparisons were made between placebo and (a) all lanadelumab‐treated patients and (b) individual lanadelumab groups for changes in scores (day 0–182) and proportions achieving the minimal clinically important difference (MCID, −6) in AE‐QoL total score. Results Compared with the placebo group, the lanadelumab total group demonstrated significantly greater improvements in AE‐QoL total and domain scores (mean change, −13.0 to −29.3; p, In the phase 3 HELP Study, HRQoL (health‐related quality of life) of patients with HAE (hereditary angioedema)‐1/2 was evaluated using the angioedema‐specific AE‐QoL (Angioedema Quality of Life Questionnaire). After 26 weeks, lanadelumab‐treated patients experienced significantly greater HRQoL improvements than placebo‐treated patients. Patients receiving lanadelumab 300 mg q2wks (every 2 weeks) were most likely to see clinically meaningful benefit, with 81% reaching the MCID (minimal clinically important difference) and seven times greater odds vs placebo for this achievement. Abbreviations: AE‐QoL, Angioedema Quality of Life Questionnaire; HAE, hereditary angioedema; HRQoL, health‐related quality of life; MCID, minimal clinically important difference; q2wks, every 2 weeks; q4wks, every 4 weeks.

Background Gastrointestinal hormones regulate intestinal transit, control digestion, influence appetite and promote satiety. Altered production or action of gut hormones, including glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) and peptide YY (PYY), may contribute to the biological basis of obesity and altered glucose homeostasis. However, challenges in analytical methodology and lack of clarity on expected values for healthy individuals have limited progress in this field. The aim of this study was to describe expected concentrations of gastrointestinal and pancreatic hormones in healthy volunteers following a standardized meal test (SMT) or 75 g oral glucose tolerance test (OGTT). Methods A total of 28 healthy volunteers (12 men, 16 women; mean age 31.3 years; mean body mass index 24.9 kg/m2) were recruited to attend a hospital clinic on two occasions. Volunteers had blood sampling in the fasting state and were given, in randomized order, an oral glucose tolerance test (OGTT) and standardized mixed liquid meal test with venepuncture at timed intervals for 4 h after ingestion. Analytical methods for gut and pancreatic hormones were assessed and optimized. Concentrations of gut and pancreatic hormones were measured and used to compile ranges of expected values. Results Ranges of expected values were created for glucose, insulin, glucagon, GLP-1, GIP, PYY and free fatty acids in response to a standardized mixed liquid meal or OGTT. Intact proinsulin and C-peptide levels were also measured following the OGTT. Conclusions These ranges of expected values can now be used to compare gut hormone concentrations between healthy individuals and patient groups.

Introduction: Patients with relapsed and refractory multiple myeloma (RRMM) have limited treatment options and experience poor health-related quality of life (HRQoL). Ide-cel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy, has shown a favorable clinical benefit-risk profile in patients with RRMM in the phase 2, single-arm KarMMa trial (Munshi NC, et al. J Clin Oncol 2020;38:8503). The impact of ide-cel treatment on primary HRQoL domains of interest preselected as most relevant for the treatment and target population (Fatigue, Pain, Cognitive Functioning, Physical Functioning, and Global Health) has been recently described (Delforge M, et al. HemaSphere 2020;4:EP1000). The aim of this analysis was to report the impact of ide-cel treatment on secondary HRQoL domains of interest and health utility scores in patients with RRMM in the KarMMa trial. Methods: Patients enrolled in the KarMMa trial (NCT03361748) had ≥ 3 prior antimyeloma treatment regimens (including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody) and were refractory to their last regimen per International Myeloma Working Group criteria. After lymphodepletion, patients received ide-cel at target dose levels of 150, 300 and 450 × 106 CAR+ T cells. HRQoL was assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life C30 (QLQ-C30) and Myeloma Module (MY20) questionnaires and the EuroQol 5 dimensions 5 levels (EQ-5D-5L) instrument at screening, baseline, on the day of ide-cel infusion, and throughout the follow-up period at Months 1-6, 9, 12, and 15 post-infusion. For each domain, clinically meaningful changes from baseline were predefined as recommended in the literature. Analyses were performed after the cutoff date, October 16, 2019, and included patients with ≥ 9+1 months of follow-up. Statistical significance was calculated using the 2-sided Wilcoxon signed-rank test (0.05 significance level). EQ-5D-5L utility indices were calculated using the UK value set as the reference country and compared with UK general population data. Results: Of 128/140 patients enrolled in the KarMMa trial who received ide-cel, 95% (EORTC QLQ-C30) and 94% (EORTC QLQ-MY20, EQ-5D-5L) had a baseline and ≥ 1 post-baseline HRQoL assessment and were evaluable for HRQoL. The compliance rate was ≥ 80% for most visits. For EORTC QLQ-C30, patients demonstrated a clinically meaningful improvement in most functioning and symptom subscale scores from baseline to Month 3 through 15, with statistical significance (p < 0.05) reached at various time points for different subscales throughout the follow-up period. For the Role Functioning, Emotional Functioning and Social Functioning subscales, > 40% of patients reported a clinically meaningful improvement from baseline, ~25% had deterioration and ~35% had no change from baseline from Month 2 onward (Figure shows Month 9 results). Stable status was most frequently observed (~60%) on the Nausea/Vomiting, Constipation, Diarrhea, Insomnia, Dyspnea and Appetite Loss, and Financial Difficulties subscales. For EORTC QLQ-MY20, the mean change from baseline on the Future Perspectives subscale demonstrated a clinically meaningful improvement from baseline at Month 2 through 15, with statistical significance (p < 0.05) reached at Month 5. Body Image subscale scores remained stable from baseline through Month 15. The greatest proportion of patients (> 48%) experienced a clinically meaningful improvement from baseline on the Future Perspective subscale. Stable status was most frequently observed (> 59%) for the Body Image subscale. Both EQ-5D-5L index (0.68 vs 0.86) and EQ visual analogue scale (EQ VAS) scores (68 vs 83) were lower for patients treated with ide-cel when compared with UK general population scores. The index and EQ-VAS mean scores became more comparable to the UK data over time, showing a clinically meaningful (although not statistically significant) improvement from baseline beginning at Month 2 (EQ-5D-5L) or 3 (EQ-VAS) through Month 15. In most patients, a clinically meaningful improvement from baseline was observed, increasing from ~43% to ~47% (EQ-5D-5L index score) and ~57% to ~68% (EQ-VAS). Conclusion: These results show that ide-cel treatment brings clinically meaningful quality-of-life benefits to triple-class-exposed patients with RRMM without compromising any HRQoL domains. Disclosures Shah: BMS, Janssen, Bluebird Bio, Sutro Biopharma, Teneobio, Poseida, Nektar: Research Funding; GSK, Amgen, Indapta Therapeutics, Sanofi, BMS, CareDx, Kite, Karyopharm: Consultancy. Delforge:Amgen: Honoraria; BMS: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Takeda: Honoraria. San-Miguel:Amgen, BMS, Celgene, Janssen, MSD, Novartis, Takeda, Sanofi, Roche, Abbvie, GlaxoSmithKline and Karyopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees. Bertin:ICON plc: Current Employment. Tahir:ICON plc: Current Employment. Lewis:ICON plc: Current Employment. Wang:Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Braverman:Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Campbell:BMS: Current Employment, Current equity holder in publicly-traded company. Dhanda:BMS: Current Employment, Current equity holder in publicly-traded company. Munshi:Takeda: Consultancy; C4: Current equity holder in private company; Janssen: Consultancy; Adaptive: Consultancy; Legend: Consultancy; Amgen: Consultancy; AbbVie: Consultancy; Karyopharm: Consultancy; OncoPep: Consultancy, Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties; BMS: Consultancy.

Acute postprandial hyperglycemia (aPPHG) is often symptomatic and can be associated with behavioral changes such as impaired working memory and attention. However, there is little evidence of the impact of aPPHG on the daily lives of patients. The aim of this study was to explore the frequency and severity of aPPHG episodes and their impact on daily functioning in people with insulin-treated diabetes.Adults (n = 1200) with insulin-treated diabetes mellitus type 1 (T1DM) or 2 (T2DM), most of whom experienced aPPHG, were recruited to complete an online cross-sectional survey in the USA and UK. The survey captured self-reported severity and frequency of aPPHG episodes and included a newly developed questionnaire (aPPHG-Q) assessing the impact of aPPHG episodes on patients' daily lives. Data was analyzed separately according to diabetes type and country. Regression analyses were used to assess the relationship between severity or frequency and scores on the aPPHG-Q.Between 70% and 86% of USA, and 87% and 88% of UK participants reported experiencing aPPHG episodes. Increasing frequency and severity of aPPHG episodes were associated with worse scores on the aPPHG-Q in patients with both T1DM and T2DM in both countries (p .014) on all subscale scores (excluding the worry and concerns scores for T1DM in the UK), although the magnitude of the association was smaller for aPPHG frequency.Increased severity and frequency of aPPHG episodes in patients with insulin-treated diabetes is associated with greater burden and experience of symptoms, and can negatively impact daily functioning.

OBJECTIVE: Larger portion sizes (PS) are associated with greater energy intake (EI), but little evidence exists on the appetitive effects of PS reduction. This study investigated the impact of reducing breakfast PS on subsequent EI, postprandial gastrointestinal hormone responses, and appetite ratings. METHODS: In a randomized crossover design (n = 33 adults; mean BMI 29 kg/m(2) ), a compulsory breakfast was based on 25% of gender-specific estimated daily energy requirements; PS was reduced by 20% and 40%. EI was measured at an ad libitum lunch (240 min) and snack (360 min) and by weighed diet diaries until bed. Blood was sampled until lunch in 20 participants. Appetite ratings were measured using visual analogue scales. RESULTS: EI at lunch (control: 2,930 ± 203; 20% reduction: 2,853 ± 198; 40% reduction: 2,911 ± 179 kJ) and over the whole day except breakfast (control: 7,374 ± 361; 20% reduction: 7,566 ± 468; 40% reduction: 7,413 ± 417 kJ) did not differ. Postprandial PYY, GLP-1, GIP, insulin, and fullness profiles were lower and hunger, desire to eat, and prospective consumption higher following 40% reduction compared to control. Appetite ratings profiles, but not hormone concentrations, were associated with subsequent EI. CONCLUSIONS: Smaller portions at breakfast led to reductions in gastrointestinal hormone secretion but did not affect subsequent energy intake, suggesting small reductions in portion size may be a useful strategy to constrain EI.

BACKGROUND: Portion size is an important component of dietary advice for weight control, but little is known about what portion sizes people consider 'normal'. This study determined the effect of body mass index (BMI), gender, dietary restraint and liking of the food on personal and social portion size norms for a range of foods and the degree of certainty over the norms. METHODS: Thirty lean (BMI 20-25 kg m(-)(2)) and 30 obese (BMI 30-35 kg m(-)(2)) men and women (aged 18-60 years) viewed 17 different portion sizes of 12 foods on a computer screen on two occasions a week apart. Participants responded 'more' or 'less' to each photograph reflecting personal portion size preference or perceived portion sizes of others. Personal and social norms for portion sizes of each food were determined using the method of constant stimuli giving a sigmoidal curve of the probability of answering 'less' over a range of portion sizes. The slope of the sigmoid at the norm gave a measure of certainty about the norm. Regression models were used to examine the effect of BMI, gender, dietary restraint and liking of the food on personal norms, social norms, the relationship between norms, and the slopes. RESULTS: Personal norms were significantly larger in the obese (P=0.026), men (P

This project was not supported by any specific funding. Claire Meek receives salary funding from the European Union Seventh Framework Programme (FP7/2007-2013; grant agreement n° 266408) and from the Wellcome Trust Translational Medicine and Therapeutics Programme which is funded by the Wellcome Trust in association with Glaxo SmithKline.

BACKGROUND Plant cell walls are known to influence the rate and extent of lipid release from plant food tissues during digestion; however, the effect of cell wall structure on postprandial lipemia is unknown. OBJECTIVE The objective was to investigate the effects of lipid release (bioaccessibility) on postprandial lipemia by comparing lipid encapsulated by cell walls with lipid present as free oil. DESIGN A randomized crossover trial (n = 20 men) compared the effects of 3 meals containing 54 g fat provided as whole almond seed macroparticles (WA), almond oil and defatted almond flour (AO), or a sunflower oil blend as control (CO) on postprandial changes in oxidative stress (8-isoprostane F(2)alpha concentrations), vascular tone (peripheral augmentation index), and plasma triacylglycerol, glucose, and insulin concentrations. RESULTS The postprandial increase in plasma triacylglycerol was lower [74% and 58% lower incremental area under curve (iAUC)] after the WA meal than after the AO and CO meals (P < 0.001). Increases in plasma glucose concentrations (0-180 min) were significantly higher after the WA meal (iAUC: 114; 95% CI: 76, 153) than after the AO meal (iAUC: 74; 95% CI: 48, 99) (P < 0.05), but no significant differences from the CO meal were observed (iAUC: 88; 95% CI: 66, 109). The peak reductions in peripheral augmentation index after the WA, AO, and CO meals (-9.5%, -10.1%, and -12.6%, respectively, at 2 h) were not significantly different between meals. Plasma 8-isoprostane F(2)alpha and insulin concentrations did not differ significantly between meals. CONCLUSIONS The bioaccessibility of lipid in almond seeds, which is regulated by the structure and properties of cell walls, plays a primary role in determining postprandial lipemia.

Background Overeating and harmful alcohol and tobacco use have been linked to the aetiology of various non-communicable diseases, which are among the leading global causes of morbidity and premature mortality. As people are repeatedly exposed to varying sizes and shapes of food, alcohol and tobacco products in environments such as shops, restaurants, bars and homes, this has stimulated public health policy interest in product size and shape as potential targets for intervention. Objectives 1) To assess the effects of interventions involving exposure to different sizes or sets of physical dimensions of a portion, package, individual unit or item of tableware on unregulated selection or consumption of food, alcohol or tobacco products in adults and children. 2) To assess the extent to which these effects may be modified by study, intervention and participant characteristics. Search methods We searched CENTRAL, MEDLINE, EMBASE, PsycINFO, eight other published or grey literature databases, trial registries and key websites up to November 2012, followed by citation searches and contacts with study authors. This original search identified eligible studies published up to July 2013, which are fully incorporated into the review. We conducted an updated search up to 30 January 2015 but further eligible studies are not yet fully incorporated due to their minimal potential to change the conclusions. Selection criteria Randomised controlled trials with between-subjects (parallel-group) or within-subjects (cross-over) designs, conducted in laboratory or field settings, in adults or children. Eligible studies compared at least two groups of participants, each exposed to a different size or shape of a portion of a food (including non-alcoholic beverages), alcohol or tobacco product, its package or individual unit size, or of an item of tableware used to consume it, and included a measure of unregulated selection or consumption of food, alcohol or tobacco. Data collection and analysis We applied standard Cochrane methods to select eligible studies for inclusion and to collect data and assess risk of bias. We calculated study-level effect sizes as standardised mean differences (SMDs) between comparison groups, measured as quantities selected or consumed. We combined these results using random-effects meta-analysis models to estimate summary effect sizes (SMDs with 95% confidence intervals (CIs)) for each outcome for size and shape comparisons. We rated the overall quality of evidence using the GRADE system. Finally, we used meta-regression analysis to investigate statistical associations between summary effect sizes and variant study, intervention or participant characteristics. Main results The current version of this review includes 72 studies, published between 1978 and July 2013, assessed as being at overall unclear or high risk of bias with respect to selection and consumption outcomes. Ninety-six per cent of included studies (69/72) manipulated food products and 4% (3/72) manipulated cigarettes. No included studies manipulated alcohol products. Forty-nine per cent (35/72) manipulated portion size, 14% (10/72) package size and 21% (15/72) tableware size or shape. More studies investigated effects among adults (76% (55/72)) than children and all studies were conducted in high-income countries - predominantly in the USA (81% (58/72)). Sources of funding were reported for the majority of studies, with no evidence of funding by agencies with possible commercial interests in their results. A meta-analysis of 86 independent comparisons from 58 studies (6603 participants) found a small to moderate effect of portion, package, individual unit or tableware size on consumption of food (SMD 0.38, 95% CI 0.29 to 0.46), providing moderate quality evidence that exposure to larger sizes increased quantities of food consumed among children (SMD 0.21, 95% CI 0.10 to 0.31) and adults (SMD 0.46, 95% CI 0.40 to 0.52). The size of this effect suggests that, if sustained reductions in exposure to larger-sized food portions, packages and tableware could be achieved across the whole diet, this could reduce average daily energy consumed from food by between 144 and 228 kcal (8.5% to 13.5% from a baseline of 1689 kcal) among UK children and adults. A meta-analysis of six independent comparisons from three studies (108 participants) found low quality evidence for no difference in the effect of cigarette length on consumption (SMD 0.25, 95% CI -0.14 to 0.65). One included study (50 participants) estimated a large effect on consumption of exposure to differently shaped tableware (SMD 1.17, 95% CI 0.57 to 1.78), rated as very low quality evidence that exposure to shorter, wider bottles (versus taller, narrower bottles) increased quantities of water consumed by young adult participants. A meta-analysis of 13 independent comparisons from 10 studies (1164 participants) found a small to moderate effect of portion or tableware size on selection of food (SMD 0.42, 95% CI 0.24 to 0.59), rated as moderate quality evidence that exposure to larger sizes increased the quantities of food people selected for subsequent consumption. This effect was present among adults (SMD 0.55, 95% CI 0.35 to 0.75) but not children (SMD 0.14, 95% CI -0.06 to 0.34). In addition, a meta-analysis of three independent comparisons from three studies (232 participants) found a very large effect of exposure to differently shaped tableware on selection of non-alcoholic beverages (SMD 1.47, 95% CI 0.52 to 2.43), rated as low quality evidence that exposure to shorter, wider (versus taller, narrower) glasses or bottles increased the quantities selected for subsequent consumption among adults (SMD 2.31, 95% CI 1.79 to 2.83) and children (SMD 1.03, 95% CI 0.41 to 1.65). Authors' conclusions This review found that people consistently consume more food and drink when offered larger-sized portions, packages or tableware than when offered smaller-sized versions. This suggests that policies and practices that successfully reduce the size, availability and appeal of larger-sized portions, packages, individual units and tableware can contribute to meaningful reductions in the quantities of food (including non-alcoholic beverages) people select and consume in the immediate and short term. However, it is uncertain whether reducing portions at the smaller end of the size range can be as effective in reducing food consumption as reductions at the larger end of the range. We are unable to highlight clear implications for tobacco or alcohol policy due to identified gaps in the current evidence base. PLAIN LANGUAGE SUMMARY Portion, package or tableware size for changing selection and consumption of food, alcohol and tobacco Review question We reviewed the evidence to establish by how much the amounts of food, alcohol or tobacco adults and children select or consume change in response to being presented with larger or smaller-sized (or differently shaped) portions or packages of these products, or of items of tableware (such as plates or glasses) used to consume them. Study characteristics This review includes 72 randomised controlled trials (RCTs) published up to July 2013 that compared at least two groups of participants, each presented with a different size of a portion, package or item of tableware. Included studies measured the amounts of food, alcohol or tobacco selected and/or consumed by participants, typically over a period of one day or less. Almost all of the included studies investigated food, with only three tobacco studies and no alcohol studies found. Almost all assessed participants' responses to different sizes rather than different shapes. The average age of participants in the different studies ranged from three to 55 years, with more studies involving adults than children and most conducted in the USA. Sources of funding were reported for the majority of studies and there was no evidence of study funding by agencies with commercial interests in their results. Key findings and quality of evidence Effects of size on consumption: We found evidence that people consistently ate more food or drank more non-alcoholic drinks when offered larger-sized portions, packages or items of tableware than when offered smaller-sized versions. We estimate the size of this effect to be small to moderate among both children and adults. If an effect of this size were sustained across the whole diet it would be equivalent to around a 12% to 16% change in average daily energy intake from food among UK adults. We rated the overall quality of the evidence for this effect as moderate, due to concern about study limitations arising from incomplete or unclear reporting of methods and procedures. From three tobacco studies, we found no effect of longer compared with shorter cigarettes on the amounts of tobacco consumed. We rated the overall quality of evidence for this effect as low due to concerns about study limitations and not having enough evidence. Effects of shape on consumption: One study found that adults provided with shorter, wider bottles drank larger amounts of water from them, having already poured more, compared with those provided with taller, narrower bottles. However, we rated the quality of this evidence as very low, due to very serious concerns about study limitations and not having enough evidence (only one study with outcome data from 50 participants). Effects of size on selection: We further found that adults, but not children, consistently chose (selected) more food (including non-alcoholic drinks) when offered larger-sized portions, packages or items of tableware than when offered smaller-sized versions. The estimated size of this effect was again small to moderate. We rated the overall quality of the evidence for this effect as moderate, due to concern about study limitations. Effects of shape on selection: Evidence from three studies suggested that adults and children provided with shorter, wider bottles or glasses selected increased quantities of non-alcoholic beverages for subsequent consumption, compared with those provided with taller, narrower bottles or glasses. We rated the quality of this evidence as low, again due to concerns about study limitations and unexplained variation in effects between the three studies. Conclusions Overall, this review provides the most conclusive evidence to date that acting to reduce the size, availability and appeal of larger-sized portions, packages and tableware has potential to reduce the quantities of food that people select and consume by meaningful amounts. However, it is uncertain whether reducing portions at the smaller end of the size range can be as effective in reducing food consumption as reductions at the larger end of the range. Our findings highlight the need for further research that aims to reduce uncertainties about these effects and address identified gaps in the evidence base, including not having enough evidence for longer-term effects and the absence of evidence about alcohol products.

Highlights • Weight loss and improved glucose tolerance after bariatric surgery have been attributed to delivery of nutrients to the lower parts of the gut. • Ileal-release of encapsulated nutrients therefore provides a potential avenue for non-surgical treatment of obesity. • In a randomised, controlled, blinded clinical study, we assessed the ability of encapsulated ileal-release glutamine to increase concentrations of total glucagon-like peptide 1 (GLP-1), improve glucose tolerance and reduce meal size. • Encapsulated glutamine did not provide consistent clinically or statistically significant increases in total GLP-1 in healthy volunteers or patients with type 2 diabetes and did not improve glucose tolerance. • We concluded that higher affinity nutrient agonists may be required to promote GLP-1 secretion., Context Weight loss and improved blood glucose control after bariatric surgery have been attributed in part to increased ileal nutrient delivery with enhanced release of glucagon-like peptide 1 (GLP-1). Non-surgical strategies to manage obesity are required. The aim of the current study was to assess whether encapsulated glutamine, targeted to the ileum, could increase GLP-1 secretion, improve glucose tolerance or reduce meal size. Methods A single-center, randomised, double blind, placebo-controlled, cross-over study was performed in 24 healthy volunteers and 8 patients with type 2 diabetes. Fasting participants received a single dose of encapsulated ileal-release glutamine (3.6 or 6.0 g) or placebo per visit with blood sampling at baseline and for 4 h thereafter. Glucose tolerance and meal size were studied using a 75 g oral glucose tolerance test and ad libitum meal respectively. Results In healthy volunteers, ingestion of 6.0 g glutamine was associated with increased GLP-1 concentrations after 90 min compared with placebo (mean 10.6 pg/ml vs 6.9 pg/ml, p = 0.004), increased insulin concentrations after 90 min (mean 70.9 vs 48.5, p = 0.048), and increased meal size at 120 min (mean 542 g eaten vs 481 g, p = 0.008). Ingestion of 6.0 g glutamine was not associated with significant differences in GLP-1, glucose or insulin concentrations after a glucose tolerance test in healthy or type 2 diabetic participants. Conclusions Single oral dosing of encapsulated glutamine did not provoke consistent increases in GLP-1 and insulin secretion and was not associated with beneficial metabolic effects in healthy volunteers or patients with type 2 diabetes.

Bariatric surgery for obesity has proved to be an extremely effective method of promoting long-term weight reduction with additional beneficial metabolic effects, such as improved glucose tolerance and remission of type 2 diabetes. A range of bariatric procedures are in common use, including gastric banding, sleeve gastrectomy and the Roux-en-Y gastric bypass. Although the mechanisms underlying the efficacy of bariatric surgery are unclear, gastrointestinal and pancreatic peptides are thought to play an important role. The aim of this review is to summarise the effects of different bariatric surgery procedures upon gastrointestinal and pancreatic peptides, including ghrelin, gastrin, cholecystokinin (CCK), glucose-dependent insulinotropic hormone (GIP), glucagon-like peptide 1 (GLP-1), peptide YY (PYY), oxyntomodulin, insulin, glucagon and somatostatin.

ObjectiveTo identify and compare suggested food portion sizes in UK schemes.DesignThe study collated and compared suggested portion sizes from selected UK schemes intended both for general advice and weight-loss advice.SettingPortion size schemes were included if they were relevant to the UK, provided actual portion size information, were intended for adults and were obtainable from the public domain in November 2010. Included schemes were from the food industry, non-governmental organisations and health-care professionals. Suggested portion sizes of foods occurring in at least one scheme for general advice and at least one scheme for weight loss were included. Own brand on-pack portion size labelling from a large UK-wide supermarket was added to represent portion size advice from UK food retailers.SubjectsNot applicable.ResultsThe suggested portion sizes in the weight-loss advice schemes were often concordant, as were the general advice schemes, except one general advice scheme from a non-governmental organisation which was more closely aligned with the portion sizes for weight loss. Overall there were substantial discrepancies between suggested portion sizes for muesli and crunchy breakfast cereals, rice, pasta and potatoes, meat, fish and pulses, whereas portion sizes for cooked vegetables, dried fruit, some breakfast cereals and cheese were broadly consistent.ConclusionsThere is a lack of consistency in the portion sizes communicated to the public. An independent and authoritative scheme of suggested portion sizes for all foods, with distinct recommendations for general advice and for weight-loss advice, could be of benefit.