Predictors Linking Obesity and the Gut Microbiome (the PROMISE Study): Protocol and Recruitment Strategy for a Cross-Sectional Study on Pathways That Affect the Gut Microbiome and Its Impact on Obesity.

BACKGROUND: The prevalence of obesity has increased substantially over recent decades and is associated with considerable health inequalities. Although the causes of obesity are complex, key drivers include overconsumption of highly palatable, energy-dense, and nutrient-poor foods, which have a profound impact on the composition and function of the gut microbiome. Alterations to the microbiome may play a critical role in obesity by affecting energy extraction from food and subsequent energy metabolism and fat storage. OBJECTIVE: We report the study protocol and recruitment strategy of the PRedictors linking Obesity and the gut MIcrobiomE (PROMISE) study, which characterizes the gut microbiome in 2 populations with different metabolic disease risk (Pacific and European women) and different body fat profiles (normal and obese). It investigates (1) the role of gut microbiome composition and functionality in obesity and (2) the interactions between dietary intake; eating behavior; sweet, fat, and bitter taste perception; and sleep and physical activity; and their impact on the gut microbiome, metabolic and endocrine regulation, and body fat profiles. METHODS: Healthy Pacific and New Zealand (NZ) European women aged between 18 and 45 years from the Auckland region were recruited for this cross-sectional study. Participants were recruited such that half in each group had either a normal weight (body mass index [BMI] 18.5-24.9 kg/m2) or were obese (BMI ≥30.0 kg/m2). In addition to anthropometric measurements and assessment of the body fat content using dual-energy x-ray absorptiometry, participants completed sweet, fat, and bitter taste perception tests; food records; and sleep diaries; and they wore accelerometers to assess physical activity and sleep. Fasting blood samples were analyzed for metabolic and endocrine biomarkers and DNA extracted from fecal samples was analyzed by shotgun sequencing. Participants completed questionnaires on dietary intake, eating behavior, sleep, and physical activity. Data were analyzed using descriptive and multivariate regression methods to assess the associations between dietary intake, taste perception, sleep, physical activity, gut microbiome complexity and functionality, and host metabolic and body fat profiles. RESULTS: Of the initial 351 women enrolled, 142 Pacific women and 162 NZ European women completed the study protocol. A partnership with a Pacific primary health and social services provider facilitated the recruitment of Pacific women, involving direct contact methods and networking within the Pacific communities. NZ European women were primarily recruited through Web-based methods and special interest Facebook pages. CONCLUSIONS: This cross-sectional study will provide a wealth of data enabling the identification of distinct roles for diet, taste perception, sleep, and physical activity in women with different body fat profiles in modifying the gut microbiome and its impact on obesity and metabolic health. It will advance our understanding of the etiology of obesity and guide future intervention studies involving specific dietary approaches and microbiota-based therapies. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000432213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370874. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/14529.

Effects of lipid emulsion particle size on satiety and energy intake: a randomised cross-over trial.

BACKGROUND/OBJECTIVES: Emulsified lipids, with central lipid core surrounded by polar lipid 'protective coat', have been proposed to stimulate the ileal brake, alter appetite, food intake and aid weight control. In addition to lipid composition, emulsion particle size may contribute to efficacy with small droplets providing a larger surface area for gastrointestinal (GI) lipase action and larger droplets prolonging and delaying digestion in the GI tract. Tube feeding studies delivering emulsions directly into the small intestine show clear effects of smaller particle size on appetite and food intake, but evidence from oral feeding studies is sparse. The objective of this study was to determine the effects of lipid emulsion particle size on appetite response and food intake. SUBJECTS/METHODS: In a three-arm randomised cross-over, high-phospholipid (PL) dairy lipid emulsions or matched control were consumed at breakfast within a yoghurt smoothie: (i) large-particle size emulsion, LPE (diameter 0.759 µm, 10 g lipid emulsion, 190 g yoghurt), (ii) small-particle size emulsion, SPE (diameter 0.290 µm, 10 g lipid emulsion, 190 g yoghurt), (iii) control non-emulsion, NE (10 g non-emulsion lipid, 190 g yoghurt). Twenty male participants completed the study, where postprandial appetite response was rated using visual analogue scales (VAS) and ad libitum energy intake at a lunch meal measured 3 h later. RESULTS: There was a trend for LPE to suppress hunger (P = 0.08) and enhance fullness (P = 0.24) relative to both SPE and NE but not statistically significant, and no significant effect of either emulsion on food intake at the lunch meal (P > 0.05). CONCLUSIONS: Altering particle size of a high-PL emulsion did not enhance satiety or alter eating behaviour in a group of lean men.

Fat Sensation: Fatty Acid Taste and Olfaction Sensitivity and the Link with Disinhibited Eating Behaviour.

Perception of fat taste, aroma, and texture are proposed to influence food preferences, thus shaping dietary intake and eating behaviour and consequently long-term health. In this study, we investigated associations between fatty acid taste, olfaction, mouthfeel of fat, dietary intake, eating behaviour, and body mass index (BMI). Fifty women attended three sessions to assess oleic acid taste and olfaction thresholds, the olfactory threshold for n-butanol and subjective mouthfeel ratings of custard samples. Dietary intake and eating behaviour were evaluated using a Food Frequency and Three-Factor Eating Questionnaire, respectively. Binomial regression analysis was used to model fat taste and olfaction data. Taste and olfactory detection for oleic acid were positively correlated (r = 0.325; p < 0.02). Oleic acid taste hypersensitive women had significantly increased n-butanol olfactory sensitivity (p < 0.03). The eating behaviour disinhibition and BMI were higher in women who were hyposensitive to oleic acid taste (p < 0.05). Dietary intake of nuts, nut spreads, and seeds were significantly correlated with high olfactory sensitivity to oleic acid (p < 0.01). These findings demonstrate a clear link between fatty acid taste sensitivity and olfaction and suggest that fat taste perception is associated with specific characteristics of eating behaviour and body composition.

Encapsulated green kiwifruit extract: a randomised controlled trial investigating alleviation of constipation in otherwise healthy adults.

OBJECTIVES: Previous clinical trials have shown bowel function is improved through consumption of whole kiwifruit (Actinidia deliciosa). This study investigated whether encapsulated kiwifruit extract (1 g/day) could alleviate constipation in otherwise healthy adults. METHODS: Forty adults with confirmed constipation entered this trial, of which 32 completed with >80% compliance. Two capsules were self-administered morning and evening for 2 periods, each of 3 weeks duration, separated by a 3+ week washout in a double blind, randomised, placebo controlled crossover. Inclusion criteria included constipation with <=3 bowel movements (BM) per week. Daily records of defecation frequency and stool characteristics were obtained throughout treatment, as well as a measurement of gastrointestinal symptoms rating scale (GSRS) and quality of life (QoL) before and after each intervention arm. RESULTS: There was no difference in total BM over 3 weeks (p>0.05) or mean BM during each of weeks 1, 2 and 3 (p>0.05) between the kiwifruit extract and placebo when assessed from a faecal diary. There was also no detectable difference in defecation related scores of BM ease of defecation, volume, consistency or BM type assessed using Bristol stool chart scores. Nor was there a significant change in GSRS or QoL between pre and post treatment measures, when compared to placebo (p>0.05). CONCLUSIONS: This trial showed that improvement in bowel function or comfort was not achieved through supplementation with 1 g/day freeze dried kiwifruit extract. Efficacy from prior kiwifruit powder and whole fruit trials indicate that investigating higher doses of encapsulated kiwifruit extract may be worthwhile.

Investigating acute satiation and meal termination effects of a commercial lipid emulsion: A breakfast meal study.

BACKGROUND: Early clinical studies showed the commercial lipid emulsion Fabuless™ to decrease energy intake (EI) and prevent weight regain, but later studies have failed to confirm this finding. Where appetite suppression has been observed it is commonly attributed to the ileal brake, where emulsified fats pass undigested to the distal small intestine and promote later satiety, but satiety profiles suggest possible transient effects within 15 min. The aim of this study was to determine whether this emulsion promotes short-term satiation and meal termination. METHODS: In a randomised cross-over intervention 18 lean men were given 4 lipid preloads immediately prior to a breakfast meal, during which ad libitum food consumption, time to meal termination and VAS-rated appetite scores were measured. Preloads were given as lipid emulsion and lipid control, both alone as a 'shot' and combined with a dairy yoghurt: (i) lipid emulsion alone (LE, Fabuless™ 4.2g lipid, 0.2MJ), (ii) lipid control alone (LC, 4.2g lipid, 0.2 MJ), (iii) LE+yoghurt (1.2 MJ), (iv) LC+yoghurt (1.2MJ). RESULTS: Whilst both yoghurt preloads suppressed EI at breakfast relative to the 'shots', as expected, neither lipid emulsion suppressed EI or triggered more rapid meal termination when compared to energy matched lipid controls (P>0.05). There was also no difference in VAS-assessed appetite scores between emulsion and control, for either preload. CONCLUSIONS: When consumed with a meal there was no evidence in lean men that this commercial lipid emulsion promotes satiation or suppresses short-term food intake.

Postprandial effects of a polyphenolic grape extract (PGE) supplement on appetite and food intake: a randomised dose-comparison trial.

BACKGROUND: There is recent evidence that glucose delivered to the distal small intestine (SI) may stimulate the ileal brake and inhibit appetite. High polyphenolic grape extract (PGE) has been shown to inhibit α-amylase and α-glucosidase activity, two key enzymes required for starch digestion, in vitro. It is hypothesised to slow digestion and absorption of starch in the proximal SI such that glucose may be delivered distally into the ileum and suppress appetite. This study investigated the safety and efficacy of a PGE supplement, delivered within a capsule and consumed with a high-starch breakfast, on appetite ratings and ad libitum energy intake (EI) at a subsequent lunch meal. METHODS: Twenty healthy, non-obese (BMI 18-28 kg/m(2)) male volunteers participated in a randomised, double blind, placebo controlled, three arm, cross-over study. Participants were administered (i) low dose PGE500 (500 mg), (ii) high dose PGE1500 (1500 mg), and (iii) matched placebo with a 2 MJ high-starch breakfast (white bread); followed 3 h later by a single item buffet-style lunch meal (pasta and meat sauce). Outcome variables were feelings of hunger, fullness, prospective thoughts of food (TOF) and satisfaction assessed using visual analogue scales (VAS); and ad lib energy and macronutrient intake at the lunch meal. RESULTS: There was no detectable effect of PGE500 or PGE1500 compared with placebo (all, time*supplement interaction, P > 0.05) on VAS-assessed hunger, fullness, TOF or satisfaction. There was also no evidence that PGE significantly altered ad lib energy or macronutrient intake at the lunch meal relative to placebo (P > 0.05). EI following PGE500 was +164 kJ higher than placebo (+5.3%, P > 0.05); and EI following PGE1500 was -51 kJ lower than placebo (-1.7%, P > 0.05). CONCLUSIONS: Whilst well tolerated, there was no evidence that encapsulated low dose PGE500 or high dose PGE1500 consumed with a high starch breakfast meal altered postprandial hunger, fullness, TOF or satisfaction relative to a matched placebo. Nor was there evidence that either dose altered ad lib energy or macronutrient intake at an outcome meal. TRIAL REGISTRATION: ACTRN12614000041651.