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

NCT ID: NCT05207488

Last Updated: 2022-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-09-20

Brief Summary

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

Detailed Description

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Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
The study is a double-blind, placebo-controlled study.

Study Groups

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Exercise + Prebiotic

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).

Group Type EXPERIMENTAL

Fructooligosaccharides (FOS)

Intervention Type DIETARY_SUPPLEMENT

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

Exercise

Intervention Type 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

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).

Group Type PLACEBO_COMPARATOR

Exercise

Intervention Type 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.).

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Fructooligosaccharides (FOS)

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

Intervention Type DIETARY_SUPPLEMENT

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.).

Intervention Type BEHAVIORAL

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Maltodextrin

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mikaela Webb, BS, RD

Role: CONTACT

(217) 300-9577

Facility Contacts

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Mikaela Webb, BS, RD

Role: primary

Other Identifiers

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21730

Identifier Type: -

Identifier Source: org_study_id

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