Effects of exercise on gut bacteria, mood, and cognition in depression

Investigating the Effects of an Exercise Intervention on Gut Bacteria, Mood and Cognition in Individuals With Major Depressive Disorder

This study is testing whether a 12-week exercise program can improve mood, thinking, and gut health in people with Major Depressive Disorder.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 59 Years
• Sex: All
• Sponsor: University College Cork (Academic / other)
• Locations: 1 site (Cork, Cork County)
• Trial ID: NCT06398496 on ClinicalTrials.gov

What this trial studies

This study investigates how a 12-week aerobic exercise program impacts individuals with Major Depressive Disorder (MDD). Participants will undergo assessments of cognition, cardiorespiratory fitness, stress, mood, and gut bacteria before, during, and after the intervention. The research aims to explore the relationship between exercise, gut microbiome changes, and improvements in depressive symptoms. Given the limitations of current treatments for MDD, this study seeks to provide insights into alternative therapeutic options through lifestyle changes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 59 who are in generally good health and have a current diagnosis of Major Depressive Disorder.

Not a fit: Patients with significant coexisting illnesses or those who have recently changed their pharmacological therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a novel, non-pharmacological treatment option for patients with Major Depressive Disorder.

How similar studies have performed: Other studies have shown promising results with exercise interventions in improving depressive symptoms, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Be able to give written informed consent.
* Be between 18 and 59 years of age.
* Be in generally good health as determined by the investigator (excluding Major Depressive Disorder diagnosis).
* Community dwelling with a current diagnosis of Major Depressive Disorder, and current depression episode/symptoms as determined via Beck's depression inventory-II (score 13-31).

Exclusion Criteria:

* Change of pharmacological therapy less than 2 weeks prior to beginning of study (including beginning pharmacological treatment).
* Have a significant acute or chronic coexisting illness \[cardiovascular, gastrointestinal (GI) \[including functional GI disorders, inflammatory bowel disease, coeliac disease\], immunological, psychiatric \[to include formal/clinical diagnosis or as determined via participant self-report i.e., bipolar spectrum disorder, schizophrenia, or psychosis, but not anxiety disorder\], neurodevelopmental or neurodegenerative disorders, metabolic disorders \[to include type I or II diabetes\], or any condition which contraindicates, in the investigators judgement, entry to the study (including conditions which may prevent an individual from safely participating in low-to-moderate exercise intensities (57-76% heart rate max \[HRmax\], rating of perceived exertion \[RPE\]:9-13 (13))-i.e., cardiorespiratory disease\[s\]).
* Have a malignant disease or any concomitant end-stage organ disease.
* Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results; to include anti- inflammatory drugs, corticosteroids, laxatives, enemas, proton-pump inhibitors, antibiotics, or probiotics (within 1 month of starting study), anti-coagulants, thrombocyte-aggregation blocking medication(s) and over-the counter non-steroidal analgesics. Participants should have a wash-out period of four-weeks of the above-mentioned medication to be eligible for participation.
* Individuals who are considered to be poor attendees, in the opinion of the investigator, or unlikely for any reason to be able to comply with the trial.
* Participants must not be currently receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.
* Are meeting the national physical activity guidelines (16) (i.e., at least 30 minutes a day of moderate intensity activity, five days a week (or 150 minutes a week), specifically in relation to structured aerobic exercise, as assessed via the international physical activity questionnaire (IPAQ). NB: if guidelines are met from occupational or incidental physical activity, individuals would not meet exclusion criteria.
* Current perimenopause, menopause, or post-menopause, in the case of females.
* Females who are pregnant, planning a pregnancy within duration of the study intervention period, or currently lactating.
* Participants who are not fluent in English or English is not first language.
* Are colour blind.
* Have dyslexia or dyscalculia.
* Are a current habitual daily smoker.
* Regular, illegal drug use.
* Alcohol abuse disorder.
* Acute suicidality or suicide attempt in the past 6 months.
* Current eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder).

Where this trial is running

Cork, Cork County

• University College Cork, APC Microbiome Ireland — Cork, Cork County, Ireland (Recruiting)

Study contacts

• Principal investigator: Gerard Clarke, PhD — University College Cork, APC Microbiome Ireland
• Study coordinator: Move4Mood Study Recruitment

Conditions Depressive Disorder, Major; gut bacteria; exercise; cardiorespiratory fitness; negative biases