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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: move4mood@ucc.ie
• Phone: (+353) 021 4901721

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.