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The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression
RECRUITINGN/ASponsored by University College Cork
Actively Recruiting
PhaseN/A
SponsorUniversity College Cork
Started2024-02-14
Est. completion2026-03
Eligibility
Age18 Years – 59 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06398496
Summary
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.
Eligibility
Age: 18 Years – 59 YearsHealthy volunteers accepted
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).
Conditions2
DepressionDepressive Disorder, Major
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Actively Recruiting
PhaseN/A
SponsorUniversity College Cork
Started2024-02-14
Est. completion2026-03
Eligibility
Age18 Years – 59 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06398496