Actively Recruiting

Phase Not Applicable
Age: 21Years - 40Years
FEMALE
Healthy Volunteers
ID06691100

The Acute Effects of an Endurance Exercise Bout on the Gut Microbiome and Gut-derived Metabolome in Women with Distinct Fitness and Body Mass Indexes

Led by George Washington University · Updated on 2025-07-24

40

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study how a single session of aerobic exercise affects the gut microbiome and metabolome in adult premenopausal women with different fitness levels and body mass indexes (BMI), including those with obesity and without. The study focuses on understanding changes in short-chain fatty acid-producing bacteria and their metabolic activity in response to a 30-minute exercise bout. It also explores changes in gut microbiome-released metabolites in stool and blood samples. Participants will engage in a 30-minute cycling exercise at 60 to 70% of their heart rate reserve during the study. The study involves three in-person visits: a baseline visit for health and fitness assessments including strength and endurance tests, and body composition analysis; an exercise test day with blood draws before and after exercise along with stool sample collection; and a follow-up visit 24 hours later for additional blood and stool sample collection and to return monitoring devices. Participants will also track their diet and physical activity throughout the study. Throughout the trial, participants will undergo detailed evaluations including stool and blood sample collection, strength and cardiovascular fitness testing, and body composition analysis via DXA scan. Researchers will monitor the gut microbiome composition and function, as well as plasma and stool metabolome at multiple time points. Safety measures include monitoring for adverse effects from blood draws, stool collection, and exercise, with confidentiality maintained through de-identified data. The total study duration for each participant spans approximately three visits over a few weeks.

CONDITIONS

Brief Title

How a Single Workout Affects Gut Bugs in Women With Different Fitness Levels and Body Types

Who Can Participate

Age: 21Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Biological sex: female
  • BMI between 19 and 24.99 kg/m2 or between 30 and 40 kg/m2
  • Exercisers must engage in at least 4 sessions per week, 60 minutes each, in endurance, strength, or team sports
  • Non-exercisers are sedentary individuals not meeting physical activity guidelines (150 minutes moderate or 75 minutes vigorous activity weekly)
Not Eligible

You will not qualify if you...

  • Biological sex: male
  • BMI less than 19 kg/m2 or greater than 40 kg/m2
  • Currently pregnant, less than 2 years postpartum, or lactating
  • Taking any herbal, fiber, or prebiotic supplements
  • Using oral or vaginal antibiotics currently or within 1 month prior to study
  • Diagnosed with gastrointestinal, endocrine, digestive, cancer, or cardiovascular disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessment

Duration - 1 day

Participants attend a baseline visit where they provide consent, complete health and lifestyle questionnaires, undergo body composition and strength tests, complete a cardiovascular fitness test, and receive equipment and instructions for at-home data collection.

1 visit (in-person)

Exercise Intervention

Duration - 1 day, 7 to 12 days after baseline

Participants perform a supervised 30-minute aerobic exercise bout on a cycle ergometer at 60 to 70% of their heart rate reserve. Blood samples and stool samples are collected before and immediately after exercise.

1 visit (in-person)

Post-exercise Follow-up

Duration - 1 day, 24 hours after exercise intervention

Participants return for a follow-up visit 24 hours after the exercise bout to provide blood and stool samples, return the accelerometer, and receive a final report on their fitness and body composition.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Milken Institute School of Public Health, The George Washington University

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

Actively Recruiting

Loading map...

Research Team

C

Carmen Ortega-Santos, PhD, RD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

Similar Trials

A Bilingual Virtually-based Intervention (PEDALL) for the Pr...

Acute Lymphoblastic Leukemia

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here