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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05207488
Other study ID # 21730
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2021
Est. completion date September 20, 2023

Study information

Verified date November 2022
Source University of Illinois at Urbana-Champaign
Contact Mikaela Webb, BS, RD
Phone (217) 300-9577
Email mwebb24@illinois.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date September 20, 2023
Est. primary completion date September 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 45 Years
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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Fructooligosaccharides (FOS)
FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water.
Behavioral:
Exercise
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.).
Dietary Supplement:
Placebo
Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.

Locations

Country Name City State
United States University of Illinois at Urbana-Champaign Urbana Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in lipid profiles Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting lipid profiles including cholesterol and triglycerides compared to control. Baseline & 6-week mark
Primary Changes in gastrointestinal microbiota composition 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. Baseline & 6-week mark
Primary Changes in gastrointestinal microbial-derived metabolite concentrations Determine the impact of daily consumption of prebiotic combined with regular exercise on the concentration of short-chain fatty acids compared to control. Baseline & 6-week mark
Secondary Changes in fasting glucose Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting glucose compared to control. Baseline & 6-week mark
Secondary Changes in fasting insulin Determine the impact of daily consumption of prebiotic combined with regular exercise on fasting insulin compared to control. Baseline & 6-week mark
Secondary Changes in body composition 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. Baseline & 6-week mark
Secondary Changes in body fat distribution 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. Baseline & 6-week mark
Secondary Changes in cognition 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. Baseline & 6-week mark
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