Recruiting

Gut Bugs

Sponsor:

George Washington University

Code:

NCT06691100

Conditions

Weight Management

Obesity

Exercise

Women

Gut Microbiome

Eligibility Criteria

Sex: Female

Age: 21 - 40

Healthy Volunteers: Accepted

Interventions

Aerobic Exercise

Study Details

Brief summary:

This study aims to elucidate the differences in the gut microbiome functional activity and metabolome in adult premenopausal women with distinctive fitness levels and BMIs (with obesity, w/o obesity). The specific aims are as follows:

  • Aim 1: To examine the effects of acute aerobic exercise at 60-70% heart rate reserve (HRRmax) for 30 minutes bout on changes in the abundance of SCFA-producing bacteria and their functional downstream metabolic activity.
  • Aim 2: To examine the effects of acute aerobic exercise at 60-70% HRRmax 30-minute bout on changes in GM-released SCFA concentrations in stool and plasmatic metabolome.

Conditions

Weight Management

Obesity

Exercise

Women

Gut Microbiome

Study ID

NCT06691100

Start date

Oct 16, 2024

Status verified date

Sep, 2026

Completion date

Oct 16, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Biological sex: female
  • BMI 19 to 24.99 kg/m2 or BMI 30-40 kg/m2
  • Exercisers: Exercise at least 4 times per week for 60 minutes (a total of 240 minutes per week) on a programmed exercise training either on endurance sports (e.g., running, cycling, triathlon), strength (e.g., powerlifting), or team sports (e.g., rugby, football, soccer)
  • Non-Exercisers: Sedentary individuals who have not reached the PA guidelines (150 minutes of moderate-intensity physical activity a week, 75 minutes of vigorous-intensity physical activity, or an equivalent combination of moderate and vigorous-intensity physical activity).

Exclusion Criteria:

  • Biological sex: male
  • BMI < 19 kg/m2 or > 40 kg/m2
  • Currently pregnant, < 2 years postpartum, lactating
  • Currently taking any herbal, fiber, or prebiotic supplement
  • Current or 1-month before the study, taking oral or vaginal antibiotics
  • Diagnosed with any gastrointestinal, endocrine, digestive, cancer, or cardiovascular disease.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

30-minute exercise bout in a cycle ergometer at 60 to 70% of the Heart Rate Reserve (HRR) and corresponding power (watts).

Interventions

Aerobic Exercise

30-minute exercise bout in a cycle ergometer at 60 to 70% of the Heart Rate Reserve (HRR) and corresponding power (watts).

Primary outcome measure

  • Gut Microbiome Composition [ Time Frame: Before the exercise intervention and immediately after the intervention ]
  • Gut Microbiome Function [ Time Frame: Before the exercise intervention and immediately after the intervention ]
  • Plasma Metabolome [ Time Frame: Before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention ]
  • Stool Metabolome [ Time Frame: Before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention ]

Central Contacts and Locations

Central contacts

Carmen Ortega-Santos, PhD, RD

2029942757carmen.ortegasantos@gwu.edu

Locations

Milken Institute School of Public Health, The George Washington University

Recruiting

Washington D.C., District of Columbia, United States, 20037

Contacts

Carmen Ortega-Santos, PhD, RD

202-994-2757carmen.ortegasantos@gwu.edu

More Information

Sponsor

George Washington University

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Gut Microbiota
  • Womens Health
  • Exercise
  • Weight Management
  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Washington University on 2026-09-09.