Aerobic Exercise for Gut Health

(FITGut-W Trial)

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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Aerobic Exercise for Gut Health?

Research shows that aerobic exercise improves cardiovascular fitness, reduces stress, and enhances overall health, which can indirectly support gut health by promoting a healthier lifestyle and reducing risk factors associated with gut-related issues. ^{1 2 3 4 5}

Is aerobic exercise generally safe for gut health?

Aerobic exercise is generally considered safe and has many health benefits, including potential improvements in gut health. While it can temporarily increase intestinal permeability, regular exercise over time may actually enhance gut integrity and reduce risks of gastrointestinal issues. ^{6 7 8 9 10}

How does aerobic exercise as a treatment for gut health differ from other treatments?

Aerobic exercise is unique because it naturally alters the gut microbiota (the community of microbes in the gut) and improves cardiorespiratory fitness, which may not be directly targeted by other treatments. Unlike medications, it involves physical activity that can enhance overall health and potentially prevent chronic diseases by promoting beneficial changes in gut bacteria. ^{11 12 13 14 15}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise training on cardiorespiratory function in men and women older than 60 years of age. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise training and relaxation training on cardiovascular activity during psychological stress. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity and exercise training prescriptions for patients. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise and intestinal permeability: another form of exercise-induced hormesis? [2020]

7. United States 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. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Aerobic Exercise Training with Brisk Walking Increases Intestinal Bacteroides in Healthy Elderly Women. [2023]

9. England 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. [2013]

10. Germany 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. [2021]

11. Switzerland 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. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Exercise and the Gut Microbiome: A Review of the Evidence, Potential Mechanisms, and Implications for Human Health. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Differences in gut microbiota profile between women with active lifestyle and sedentary women. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Exercise and gut immune function: evidence of alterations in colon immune cell homeostasis and microbiome characteristics with exercise training. [2018]

15. United States pubmed.ncbi.nlm.nih.gov

Gut Microbiota Composition Is Related to Cardiorespiratory Fitness in Healthy Young Adults. [2020]