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

NCT06691100 | Recruiting

• 1 other identifier: NCR245983
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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; Metabolome; Health; Gut Microbiota

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Gut Microbiome Composition

  Shotgun metagenomics will be used to examine the abundance of specific SCFA-producing bacteria in the stool (e.g., Ruminococcus)

  Before the exercise intervention and immediately after the intervention

• Gut Microbiome Function

  Shotgun metagenomics will be used to examine the BGCs (i.e., the genes within the microbial genome that dictate gut microbial functionality) to investigate functional downstream metabolic activity.

  Before the exercise intervention and immediately after the intervention

• Plasma Metabolome

  Gas chromatography and mass spectrometry will be used to measure concentrations of SCFAs in plasma before and after the exercise intervention

  Before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention

• Stool Metabolome

  Gas chromatography and mass spectrometry will be used to measure concentrations of SCFAs in stool before and after the exercise intervention

  Before the exercise intervention, immediately after the exercise intervention, and 24 hours before the intervention

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

Interventions

Aerobic Exercise BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 21 Years - 40 Years
• Gender Eligibility Details: Sex assigned at birth: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

Milken Institute School of Public Health, The George Washington University

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

RECRUITING

Related Links

• Pre-Screening Survey

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; 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

Carmen Ortega-Santos, PhD, RD

CONTACT

2029942757; carmen.ortegasantos@gwu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 15, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 16, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)