Overweight and Obesity
Conditions
Keywords
Gastrointestinal microbiota, Fructooligosaccharides, Exercise, Fiber, Prebiotic, Short-chain fatty acids, Glucose homeostasis, Body composition, Cognition
Brief summary
This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.
Interventions
FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water.
During the intervention period, all participants will perform 6 weeks of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk.).
Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.
Sponsors
Study design
Masking description
The study is a double-blind, placebo-controlled study.
Intervention model description
The study is a randomized, controlled trial with a 6-week intervention period with two groups: 1) Exercise + Prebiotic and 2) Exercise + Placebo.
Eligibility
Inclusion criteria
* BMI 18.5-45 kg/m2 * Without physician diagnosed gastrointestinal or metabolic diseases * Sedentary (\< 30 minutes of moderate or high intensity exercise per week OR \< 20 aggregate Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ; GodinLeisure) score) * Fully vaccinated against COVID-19
Exclusion criteria
* Fasting blood glucose \>126 mg/dL * Blood pressure \>160/100 mm Hg * Physician diagnosed metabolic or gastrointestinal diseases or constipation * Heart conditions that may pose risk during exercise * Taking oral hypoglycemic agents or insulin * Pregnant, breastfeeding or postmenopausal * Smoke or consume \> 2 alcoholic beverages/day, abuse drugs * Have had \> 5% weight change in the past month or \> 10% change in the past year * Have had any form of bariatric surgery or gallbladder removal * Have taken antibiotics during the previous 3 months * Unable to consume the experimental fiber
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in gastrointestinal microbial-derived metabolite concentrations | Baseline & 6-week mark | Determine the impact of daily consumption of prebiotic combined with regular exercise on the concentration of short-chain fatty acids compared to control. |
| Changes in gastrointestinal microbiota composition | Baseline & 6-week mark | Determine the impact of daily consumption of prebiotic combined with regular exercise on the gastrointestinal microbiota compared to control by sequencing the V4 region of the 16S rRNA gene in fecal samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in fasting insulin | Baseline & 6-week mark | Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control. |
| Changes in body composition | Baseline & 6-week mark | Determine the impact of daily consumption of prebiotic combined with regular exercise on body composition compared to control. This includes percentage of fat mass and lean mass. |
| Changes in cognition | Baseline & 6-week mark | Determine the impact of daily consumption of prebiotic combined with regular exercise on relational memory, hippocampal function, interference control, and selective attention compared to control. Outcomes will be assessed with computer tasks and participants will be equipped with an electrode cap. |
| Changes in body fat distribution | Baseline & 6-week mark | Determine the impact of daily consumption of prebiotic combined with regular exercise on body fat distribution compared to control. This includes the weight of visceral fat and liver fat in kilograms. |
| Changes in fasting glucose | Baseline & 6-week mark | Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in lipid profiles | Baseline & 6-week mark | Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting lipid profiles including cholesterol and triglycerides compared to control. |
Countries
United States