About this trial
Strong evidence supports the association between high fiber (HiFi) diets (e.g. legumes, nuts, vegetables) and a reduced risk for chronic conditions such as cardiovascular disease (CVD), type 2 diabetes and some forms of cancer. However, the current U.S. average consumption of dietary fiber of 17g/day is significantly below the recommendation level of 25g/d for women and 38g/d for men. Furthermore, fiber fermentation to produce short chain fatty acid (SCFA) products and alterations in microbial composition and activity may be mechanisms linking a HiFi diet to improved health. Importantly, much of the data, including findings supporting a beneficial role of SCFA have been derived from animal studies. Human studies are now needed to advance the understanding of the translational significance of rodent studies and the potential benefit of fiber on microbial metabolites and cardiometabolic health, glucose regulation, appetite and satiety. The central hypothesis is that that the mechanisms by which dietary fiber provides metabolic benefit include direct physical effects in the upper gastrointestinal tract to slow nutrient absorption, and indirect effects to reduce food intake mediated by SCFA-induced secretion of intestinal hormones resulting in increased satiety. Design: Using fiber derived from peas, Aim 1 will test the effect of a HiFi diet on appetite, satiety, and cardiometabolic health and whether elevated SCFA concentration mediates improved satiety in 44 overweight/obese subjects randomly assigned to receive either a high fiber or a low fiber dietary intervention for four weeks in a parallel arm-repeated measures design. Aim 2 will quantitate the changes in microbial composition and colonic SCFA production rate during HiFi feeding and whether any changes are potential mediators of observed benefits on satiety and cardiometabolic risk factors in 26 subjects assigned to receive a high fiber intervention for 3 weeks in a repeated measures design. Relevance: These studies will significantly expand the understanding of mechanisms by which dietary fiber improves satiety and cardiometabolic health in humans.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and women (premenopausal only)
Age 20-55y (Aim 1); 45-55y (Aim 2)
BMI ≥25 or ≤35 kg/m2 (Aim 1); ≥25 or ≤40 (Aim 2)
Weight stable (no fluctuations in body weight of greater than 4 kg in the last 3 months)
Disqualifiers
Pregnant or lactating
Postmenopausal (evidence suggests an interplay between the gut microbiome)
BMI of <25 or >35 kg/m2 (Aim 1); <25 or >40 kg/m2 (Aim 2)
Use of medications that affect the gut microbiome (e.g. antibiotics)
Trial design
Parallel
Treatments tested in this trial
Dietary fiber: 10-25g
Other intervention10-25 g/day of fiber
Dietary fiber: 5g
Other intervention5 g/day of fiber
Treatment groups
Trial outcomes
Primary outcomes
Change in microbiome composition and diversity
Fecal samples are collected on different days during the intervention for microbiome analyses using 16rRNA technique
Short chain fatty acid concentration in plasma
Plasma SCFA are analyzed using gas chromatography/mass spectrometry (GC/MS)
Short chain fatty acids enrichment
Subjects are infused with stable isotopes of the short chain fatty acids, acetate, propionate, and butyrate and then isotope dilution by an unlabeled fiber fromt he diet is used to quantify the levels of acetate, propionate and butyrate in vivo
Secondary outcomes
Change in blood oxygenation level dependent (BOLD) response
ubjects view images of food (low calorie and high calorie) and non-food while being scanned in an fMRI machine. The change in brain activation in response to the fMRI food reactivity task is measured as the BOLD response
Subjective appetite
Subjects rate on a visual analogue scale (VAS) at 8 different time points in Aim 1 and at 12 different time points in Aim 2 during each of the two meal test visits. The VAS is a 100 mm scale to determine subjective appetite measures (hunger, fullness, desire to eat and prospective consumption).
Glucose and lipids and blood pressure
During each of two meal test visits for Aim 1 and Aim 2, blood samples are taken at 8 different time points for Aim 1 and 12 different time points for Aim 2 for assessment of glucose response and lipids (TG) concentrations. Blood pressure measurements are taken at the beginning of each meal test day visit for both aims.
Change in appetite hormones (GLP-1 and PYY)
Blood is drawn at different time points in both Aims 1 and 2 during each of the two meal test visits for assessment of appetite hormone
Sponsors and contacts
Click on the lead sponsor to view all of their trials.