Aerobic Exercise for Gut Health

(FITGut-W Trial)

Recruiting at 1 trial location

Overseen By Carmen Ortega-Santos, PhD, RD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: George Washington University

Must not be taking: Herbal, Fiber, Prebiotics, Antibiotics

Disqualifiers: Male, Pregnancy, Gastrointestinal, Endocrine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how short bouts of aerobic exercise affect gut health in women, focusing on changes in gut bacteria and related chemicals after exercise. Participants will cycle for 30 minutes at a specific heart rate. Women who exercise regularly or are mostly inactive, within specific body weight ranges, may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of exercise and gut health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking any herbal, fiber, or prebiotic supplements, or if you have taken antibiotics in the past month.

What prior data suggests that aerobic exercise is safe for gut health?

Research shows that aerobic exercise is generally safe for most people. Studies have found that regular exercise can improve gut health by increasing the variety of bacteria in the gut, which can help prevent problems like obesity and diabetes.

However, some people might experience stomach issues such as cramps or nausea during intense exercise. These effects often depend on the type and intensity of the workout and other factors like the environment.

Overall, aerobic exercise is well-tolerated and offers benefits beyond just fitness. It can improve gut health and reduce inflammation. Most people can safely engage in aerobic activities like cycling, especially at moderate levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Aerobic exercise is unique because it enhances gut health in a natural and non-invasive way, unlike standard treatments that often involve medications or dietary changes. Researchers are excited about this approach because it uses a simple mechanism—boosting physical activity—to improve the balance of gut bacteria and overall digestive health. This method is appealing because it not only targets gut health but also provides additional benefits like improved cardiovascular fitness and mental well-being, making it an all-encompassing wellness strategy.

What evidence suggests that aerobic exercise is effective for gut health?

Research shows that aerobic exercise, which participants in this trial will perform, benefits gut health. Studies have found that moderate aerobic exercise increases the variety of gut bacteria, linked to better overall health. It also boosts the number of helpful bacteria that produce short-chain fatty acids (SCFAs), important for gut health. These changes can reduce inflammation and improve gut function. Overall, regular aerobic exercise appears to create a healthier gut environment. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for premenopausal women with varying fitness levels and body sizes, specifically including those who are obese. Participants should be interested in how a single session of aerobic exercise can affect their gut bacteria.

Inclusion Criteria

My BMI is either between 19-24.99 or 30-40.

Non-Exercisers: Sedentary individuals who have not reached the PA guidelines

I am female.

Exclusion Criteria

BMI < 19 kg/m2 or > 40 kg/m2

I am currently pregnant, less than 2 years postpartum, or breastfeeding.

I am currently taking herbal, fiber, or prebiotic supplements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online questionnaire

Baseline Assessment

Participants undergo baseline assessments including demographic data collection, body composition analysis, and fitness tests

1 day

1 visit (in-person)

Exercise Intervention

Participants perform a 30-minute biking exercise at 60-70% HRR with pre- and post-exercise blood draws

1 day

1 visit (in-person)

Post-Exercise Assessment

Participants return for follow-up assessments including blood draw and return of equipment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the exercise intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise

Trial Overview

The study is testing the impact of a 30-minute aerobic workout at moderate intensity (60-70% heart rate reserve) on the gut microbiome's function and metabolites in blood and stool, focusing on short-chain fatty acid production.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Published Research Related to This Trial

A 10-week moderate aerobic exercise program significantly improved cardiorespiratory fitness (VO2peak) in 24 previously sedentary non-obese men, indicating that exercise can enhance physical fitness without altering gut bacteria diversity.

Specific gut bacteria genera, such as Roseburia and Sutterella, were positively associated with improved fitness levels, while others like Desulfovibrio were linked to body composition, suggesting a relationship between exercise, gut health, and overall fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in the Gut Bacteria Composition of Healthy Men with the Same Nutritional Profile Undergoing 10-Week Aerobic Exercise Training: A Randomized Controlled Trial. Resende, AS., Leite, GSF., Lancha Junior, AH.[2021]

Regular physical exercise, as recommended by the World Health Organization, can significantly alter the gut microbiota composition in women, promoting beneficial bacterial species.

Active women showed higher levels of health-promoting bacteria such as Faecalibacterium prausnitzii and Akkermansia muciniphila, indicating a link between physical activity, body composition, and gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in gut microbiota profile between women with active lifestyle and sedentary women. Bressa, C., Bailén-Andrino, M., Pérez-Santiago, J., et al.[2022]

Habitual physical activity is shown to be anti-inflammatory and may help prevent chronic inflammatory diseases, particularly by influencing gut health and the balance of gut microbiota.

Emerging research indicates that different types of exercise can affect the severity of intestinal inflammation, such as in conditions like ulcerative colitis, by impacting gut immune function and microbiome interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and gut immune function: evidence of alterations in colon immune cell homeostasis and microbiome characteristics with exercise training. Cook, MD., Allen, JM., Pence, BD., et al.[2018]

Regular aerobic exercise can temporarily increase intestinal permeability, but this effect is outweighed by long-term health benefits and adaptations that improve gut health over time.

Chronic exercise regimens lasting weeks to months are associated with improved markers of intestinal integrity, suggesting that the gut adapts positively to regular physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and intestinal permeability: another form of exercise-induced hormesis? Keirns, BH., Koemel, NA., Sciarrillo, CM., et al.[2020]

Structured exercise programs lasting at least 12 weeks can lead to significant changes in the gut microbiome of patients with inflammatory bowel diseases (IBD), potentially improving their condition.

These exercise-induced changes may help regulate immunometabolic pathways, suggesting that personalized exercise regimens could serve as a valuable therapeutic addition for managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Role of exercise in preventing and restoring gut dysbiosis in patients with inflammatory bowel disease": A letter to the editor. Mc Gettigan, N., O'Toole, A., Boland, K.[2022]

A 12-week exercise intervention in 32 sedentary elderly women showed that aerobic exercise training (brisk walking) significantly increased the abundance of beneficial intestinal bacteria, specifically Bacteroides.

Improvements in cardiorespiratory fitness, measured by the 6-minute walk test, were associated with the increase in Bacteroides, suggesting that aerobic exercise not only enhances physical fitness but also positively impacts gut health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Exercise Training with Brisk Walking Increases Intestinal Bacteroides in Healthy Elderly Women. Morita, E., Yokoyama, H., Imai, D., et al.[2023]

Regular low-intensity exercise significantly reduces anxiety and protects against oxidative damage in the colon, as shown in a study with Sprague-Dawley rats over 6 weeks.

The exercise group exhibited lower levels of colonic damage and inflammation compared to sedentary rats after inducing colitis, indicating that exercise may have therapeutic benefits for managing stress-related colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colitis-induced oxidative damage of the colon and skeletal muscle is ameliorated by regular exercise in rats: the anxiolytic role of exercise. Kasimay, O., Güzel, E., Gemici, A., et al.[2013]

Untrained individuals experience greater gastrointestinal barrier disruption and microbial translocation during exertional-heat stress compared to highly trained individuals, indicating that aerobic fitness may protect against these adverse effects.

The study found that untrained individuals had higher levels of intestinal fatty-acid binding protein (I-FABP) and increased microbial translocation, suggesting that regular aerobic training could enhance gastrointestinal integrity during heat stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of aerobic fitness on gastrointestinal barrier integrity and microbial translocation following a fixed-intensity military exertional heat stress test. Ogden, HB., Fallowfield, JL., Child, RB., et al.[2021]

The gut microbiota, which consists of trillions of microbes, is crucial for our health and can be significantly altered by exercise, suggesting a strong link between physical activity and gut health.

Understanding how exercise influences the gut microbiota could provide insights into improving human health and managing diseases, highlighting the importance of physical activity in maintaining a healthy microbiome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and the Gut Microbiome: A Review of the Evidence, Potential Mechanisms, and Implications for Human Health. Mailing, LJ., Allen, JM., Buford, TW., et al.[2019]

This study found a significant correlation between cardiorespiratory fitness (measured as VO2max) and the composition of gut microbiota in healthy young adults, with VO2max explaining about 22% of the variance in the Firmicutes to Bacteroidetes (F/B) ratio.

The research involved 37 participants (20 males and 17 females) and suggests that higher fitness levels may positively influence gut microbiota composition, which could have implications for overall health and potential therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut Microbiota Composition Is Related to Cardiorespiratory Fitness in Healthy Young Adults. Durk, RP., Castillo, E., Márquez-Magaña, L., et al.[2020]

High-intensity aerobic exercise training significantly improves peak oxygen consumption in heart failure patients, with a mean increase of 3.33 ml·kg(-1)·min(-1), which is a 23% improvement from baseline, compared to control groups.

No deaths were reported as directly attributable to exercise during the study, indicating that higher exercise intensity can be safely implemented in heart failure rehabilitation without increasing mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and cardiovascular responses to different exercise training intensities in patients with heart failure: a systematic review and meta-analysis. Ismail, H., McFarlane, JR., Nojoumian, AH., et al.[2022]

Students who engaged in an 11-week aerobic training program showed significant improvements in aerobic fitness compared to those in relaxation training or no treatment, highlighting the efficacy of aerobic exercise in enhancing physical fitness.

The aerobic training group also experienced greater reductions in heart rate during psychological stress, with differences reaching up to 17 beats per minute compared to the control group, suggesting that aerobic exercise can effectively lower cardiovascular responses to stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise training and relaxation training on cardiovascular activity during psychological stress. Holmes, DS., Roth, DL.[2019]

Understanding the body's response to exercise and the benefits of aerobic training allows clinicians to effectively motivate patients to engage in physical activity.

Encouraging early and continued physical activity can help individuals maintain cardiovascular fitness, strength, and flexibility as they age, promoting greater independence later in life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise and endurance: improving fitness for health benefits. Wilmore, JH.[2010]

In a study of 101 older adults (over 60 years), those who engaged in 14 months of aerobic exercise showed a 10 to 15% improvement in peak oxygen consumption, indicating enhanced aerobic capacity.

Aerobic exercise also led to significant improvements in lipid profiles, particularly increasing high-density lipoprotein (HDL) cholesterol levels, which is beneficial for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise training on cardiorespiratory function in men and women older than 60 years of age. Blumenthal, JA., Emery, CF., Madden, DJ., et al.[2019]

Regular exercise significantly increases markers of exercise capacity, such as VO2max and ventilatory threshold (VT), which can enhance overall quality of life, especially for patients with health limitations.

Exercise serves as a positive health recommendation that not only improves physical fitness but may also indirectly encourage patients to adopt healthier behaviors, contrasting with traditional negative health advice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training prescriptions for patients. Foster, C., Cadwell, K., Crenshaw, B., et al.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11547208/

Physical Exercise and the Gut Microbiome - PubMed Central

Moderate aerobic exercise boosts the production of immunoglobulin A in the gastrointestinal tract, enhancing the gut microbiota's ability to ...

2.

nature.com

nature.com/articles/s41598-023-38357-6

Aerobic exercise training and gut microbiome-associated ...

More importantly, increase in habitual physical activity can translate to enhanced microbial diversity and leverage health-beneficial taxa.

3.

gastrojournal.org

gastrojournal.org/article/S0016-5085%2825%2900329-4/fulltext

Exercise, the Gut Microbiome and Gastrointestinal Diseases

Acute exercise has diverse effects on the GI tract (Figure 2) that can broadly be divided into upper (ie, heartburn, belching, regurgitation, and epigastric ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0016508525003294

Exercise, the Gut Microbiome and Gastrointestinal Diseases

The gut microbiome has become an attractive target for modulating many of the positive effects of regular PA on GI health and disease.

5.

frontiersin.org

frontiersin.org/journals/nutrition/articles/10.3389/fnut.2021.637010/full

Interplay Between Exercise and Gut Microbiome in the ...

Moderate endurance exercise reduces inflammation, improves body composition and leads to positive effects on gut microbial diversity and composition.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8526197/

The Relationship among Physical Activity, Intestinal Flora, and ...

Exercise can effectively prevent some chronic diseases related to gut microbiota disorders, such as obesity, hypertension, diabetes, respiratory ...

7.

ahajournals.org

ahajournals.org/doi/10.1161/01.cir.0000048890.59383.8d

Exercise and Cardiovascular Health | Circulation

Over the past 4 decades, numerous scientific reports have examined the relationships between physical activity, physical fitness, and cardiovascular health.