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Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial.

ABSTRACT: Background:The goal of the Frequency of Eating and Satiety Hormones (FRESH) Study is to understand the relationship between eating frequency (EF) and biomarkers of appetite and disease risk. This report gives the study rationale and design. Methods:The FRESH study was conducted in n?=?50 overweight and obese, but otherwise healthy, male and female adults aged 18-50 years. The protocol included four in-person clinic visits for protocol instruction, blood draws, anthropometry, and meal testing; all other activities were done at home. Participants completed two 21-day phases in random order with a two-week washout between phases. One phase was high EF (6 eating occasions/day) and the other was low EF (3 eating occasions/day). Each phase specified time of day for each eating occasion. Participants prepared their own meals throughout the study using study-provided individualized, structured meal plans ensuring that calories, macronutrients and micronutrients were identical during both study phases. Fasting blood was collected before and after each phase to test intervention effects on the biomarkers. At the end of each phase participants also completed extended appetite testing with meals prepared by the study clinic. Results:Participants were recruited using print, radio, and digital ads. 60 participants consented to enroll; 10 dropped out due to work or school scheduling conflicts and 50 (target sample size) completed the study. Compliance was assessed by completion of daily on-line meal plan checklists. Conclusions:The FRESH study will provide data on whether higher vs. lower daily EF in the context of constant energy and nutrient intake may be harmful or beneficial based on intervention effects on biomarkers of health and disease risk.

SUBMITTER: Neuhouser ML

PROVIDER: S-EPMC6384307 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial.

Neuhouser Marian L ML Clowry Catherine C Beatty Sarah J SJ Wang Ching-Yun CY Drewnowski Adam A Perrigue Martine M MM

Contemporary clinical trials communications 20190215

<h4>Background</h4>The goal of the Frequency of Eating and Satiety Hormones (FRESH) Study is to understand the relationship between eating frequency (EF) and biomarkers of appetite and disease risk. This report gives the study rationale and design.<h4>Methods</h4>The FRESH study was conducted in n = 50 overweight and obese, but otherwise healthy, male and female adults aged 18-50 years. The protocol included four in-person clinic visits for protocol instruction, blood draws, anthropometry, and m ...[more]

PMID: 30834353

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Project description:BackgroundEating disorders and obesity are serious health problems with poor treatment outcomes and high relapse rates despite well-established treatments. Several studies have suggested that virtual reality technology could enhance the current treatment outcomes and could be used as an adjunctive tool in their treatment.ObjectiveThis study aims to investigate the differences between eating virtual and real-life meals and test the hypothesis that eating a virtual meal can reduce hunger among healthy women.MethodsThe study included 20 healthy women and used a randomized crossover design. The participants were asked to eat 1 introduction meal, 2 real meals, and 2 virtual meals, all containing real or virtual meatballs and potatoes. The real meals were eaten on a plate that had been placed on a scale that communicated with analytical software on a computer. The virtual meals were eaten in a room where participants were seated on a real chair in front of a real table and fitted with the virtual reality equipment. The eating behavior for both the real and virtual meals was filmed. Hunger was measured before and after the meals using questionnaires.ResultsThere was a significant difference in hunger from baseline to after the real meal (mean difference=61.8, P<.001) but no significant change in hunger from before to after the virtual meal (mean difference=6.9, P=.10). There was no significant difference in food intake between the virtual and real meals (mean difference=36.8, P=.07). Meal duration was significantly shorter in the virtual meal (mean difference=-5.4, P<.001), which led to a higher eating rate (mean difference=82.9, P<.001). Some participants took bites and chewed during the virtual meal, but the number of bites and chews was lower than in the real meal. The meal duration was reduced from the first virtual meal to the second virtual meal, but no significant difference was observed between the 2 real meals.ConclusionsEating a virtual meal does not appear to significantly reduce hunger in healthy individuals. Also, this methodology does not significantly result in eating behaviors identical to real-life conditions but does evoke chewing and bite behavior in certain individuals.Trial registrationClinicalTrials.gov NCT05734209, https://clinicaltrials.gov/ct2/show/NCT05734209.

Project description:Lysine is the second most limiting amino acid after methionine and is considered the most limiting amino acid for growth in poultry. Lysine requirement for broiler chickens has changed over the years. Leptin and adiponectin represent 2 adipokines that mediate metabolism by eliciting satiety effects whereas ghrelin peptide hormone influences appetite. We hypothesize that this affects growth performance of chicks. This study evaluates the effect of varying dietary lysine homeostasis on performance of broiler chickens through satiety- and appetite-mediating hormones. In 3 replications, 270 one-day-old chicks were reared for 8 wk feeding on diets comprising 0.85, 1.14, and 1.42% lysine during the starter period and 0.75, 1.00, and 1.25% lysine during the grower period. These concentrations of lysine represent 75% (low lysine), 100% (control), and 125% (high lysine) of National Research Council recommendation for broiler chickens. Feed and water were provided for ad libitum consumption. At 8 wk of age, liver, pancreas, brain, and hypothalamus tissues were collected from 18 birds randomly selected from each treatment, snap frozen in liquid nitrogen, and stored at -80°C until use. Total RNA was extracted, and cDNA was synthesized for quantitative real-time PCR assays. Low lysine concentration caused slow growth and high mortality. There was significant upregulation of ghrelin in the hypothalamus and pancreas, and leptin and adiponectin in the hypothalamus and liver, and downregulation of ghrelin in the intestines. At low lysine concentrations, adiponectin was not expressed in both pancreas and intestines. High lysine concentration exhibited increased growth, upregulation of ghrelin in the liver, and downregulation of ghrelin in the intestines, and both adiponectin and leptin in the liver. The expression of ghrelin was negatively correlated with the expression of adiponectin and leptin (P < 0.05) in the liver, hypothalamus, and pancreas. Expression of leptin was positively correlated with adiponectin in the hypothalamus and liver (P < 0.05), exhibiting satiety effects when the concentrations of lysine were low.

Project description:BACKGROUND:Although insufficient sleep has emerged as a strong, independent risk factor for obesity in children, the mechanisms by which insufficient sleep leads to weight gain are uncertain. Observational research suggests that being tired influences what children eat more than how active they are, but only experimental research can determine causality. Few experimental studies have been undertaken to determine how reductions in sleep duration might affect indices of energy balance in children including food choice, appetite regulation, and sedentary time. The primary aim of this study is to objectively determine whether mild sleep deprivation increases energy intake in the absence of hunger. METHODS:The Daily, Rest, Eating, and Activity Monitoring (DREAM) study is a randomized controlled trial investigating how mild sleep deprivation influences eating behaviour and activity patterns in children using a counterbalanced, cross-over design. One hundred and ten children aged 8-12?years, with normal reported sleep duration of 8-11?h per night will undergo 2 weeks of sleep manipulation; seven nights of sleep restriction by going to bed 1 hr later than usual, and seven nights of sleep extension going to bed 1 hr earlier than usual, separated by a washout week. During each experimental week, 24-h movement behaviours (sleep, physical activity, sedentary behaviour) will be measured via actigraphy; dietary intake and context of eating by multiple 24-h recalls and wearable camera images; and eating behaviours via objective and subjective methods. At the end of each experimental week a feeding experiment will determine energy intake from eating in the absence of hunger. Differences between sleep conditions will be determined to estimate the effects of reducing sleep duration by 1-2?h per night. DISCUSSION:Determining how insufficient sleep predisposes children to weight gain should provide much-needed information for improving interventions for the effective prevention of obesity, thereby decreasing long-term morbidity and healthcare burden. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12618001671257 . Registered 10 October 2018.

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Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial.

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Rationale and design of the frequency of eating and Satiety Hormones (FRESH) study: A randomized cross-over clinical trial.

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