NCT06398496Recruiting
The 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
Source: ClinicalTrials.gov · Last updated 8 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to investigate the effects of a 12-week aerobic (cardio) exercise intervention in people with Major Depressive Disorder. Measurements taken before, during, and following the 12-week intervention will include assessments of cognition, cardiorespiratory fitness, stress, mood and emotion, and gut bacteria.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 May 2024
- Start date
- 14 Feb 2024
- Primary completion date
- Mar 2026
- Lead sponsor
- University College Cork
- Diseases
- Depression
- NCT number
- NCT06398496
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 14 Feb 2024 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Change of pharmacological therapy less than 2 weeks prior to beginning of study (including beginning pharmacological treatment).
- Have a malignant disease or any concomitant end-stage organ disease.
- 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.
- Regular, illegal drug use.
Other illness
- 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\[s\]).
- 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.
- Alcohol abuse disorder.
- Current eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder).
Other
- 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.
- 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.
- Acute suicidality or suicide attempt in the past 6 months.
Who the study is looking for
- 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).
Age in the registry: 18 years to 59 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College Cork, APC Microbiome Ireland Coordinator of this site? Confirm its status | Cork | Ireland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.