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

University of Illinois at Urbana-Champaign

Status: Enrolling

Conditions: Overweight and Obesity

Treatments: Dietary Supplement: Fructooligosaccharides (FOS); Dietary Supplement: Placebo; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05207488

21730

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Exercise + Prebiotic

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Fructooligosaccharides (FOS)

Behavioral: Exercise

Exercise + Placebo

Placebo Comparator group

Description:

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).

Treatment:

Dietary Supplement: Placebo

Behavioral: Exercise