Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention

NCT05207488 | Unknown

• 1 other identifier: 21730
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Gastrointestinal microbiota; Fructooligosaccharides; Exercise; Fiber; Prebiotic; Short-chain fatty acids; Glucose homeostasis; Body composition; Cognition

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Changes in fasting glucose

  Baseline & 6-week mark

• Changes in fasting insulin

  Baseline & 6-week mark

• Changes in body composition

  Baseline & 6-week mark

• Changes in body fat distribution

  Baseline & 6-week mark

• Changes in cognition

  Baseline & 6-week mark

Other Outcomes (1)

• Changes in lipid profiles

  Baseline & 6-week mark

Study Arms (2)

Exercise + Prebiotic

EXPERIMENTAL

The Exercise + Prebiotic intervention group will consume 10 g/d of fructo-oligosaccharides (FOS). Additionally, they will perform 6 wk. of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk).

Dietary Supplement: Fructooligosaccharides (FOS); Behavioral: Exercise

Exercise + Placebo

PLACEBO COMPARATOR

The Exercise + Placebo group will consume 10 g/d of a placebo (maltodextrin) powder every day. Additionally, they will perform 6 wk. of supervised progressive multi-component exercise training consisting of moderate to vigorous aerobic and strength-based exercises (3x/wk).

Behavioral: Exercise; Dietary Supplement: Placebo

Interventions

Fructooligosaccharides (FOS) DIETARY_SUPPLEMENT

FOS (NUTRAFLORA® P-95, Ingredion) supplements (10g/day) will be consumed daily mixed with water.

Exercise + Prebiotic

Exercise BEHAVIORAL

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.).

Exercise + Placebo; Exercise + Prebiotic

Placebo DIETARY_SUPPLEMENT

Maltodextrin (Globe 18DE Maltodextrin, Ingredion) supplements (10g/day) will be consumed daily mixed with water.

Also known as: Maltodextrin

Exercise + Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Interventions

fructooligosaccharide; Exercise; maltodextrin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mikaela Webb, BS, RD

CONTACT

(217) 300-9577; mwebb24@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is a double-blind, placebo-controlled study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a randomized, controlled trial with a 6-week intervention period with two groups: 1) Exercise + Prebiotic and 2) Exercise + Placebo.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: January 26, 2022
• Study Start: October 1, 2021
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)