The Effects of Exercise on Gut Bacteria, Mood and Cognition in Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorUniversity College Cork

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic Exercise

    Behavioral

    Aerobic exercise intervention will involve multiple exercise sessions completed (unsupervised) by participants. Exercise programs will be given to participants, matched to their current level of fitness as determined via a maximal cardiorespiratory fitness test, and will be adjusted via progressive overload every 1-2 weeks by an exercise and sports science professional.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: Aerobic Exercise + Usual CareExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Depression symptom change

Depression symptoms measured via self-report questionnaire (Beck's Depression Inventory-II).

Time frame
Change from baseline at 12-weeks
2

Negative and positive affect change

Negative and positive affect, measured via self-report positive affect negative affect schedule.

Time frame
Change from baseline at 12-weeks
3

Gut microbiota change

Gut microbiota, measured via sequencing of stool samples (including measures of diversity, composition, and function).

Time frame
Change from baseline at 12-weeks
4

Cognitive performance: affective perceptual bias

Emotional bias, measured via Emotional bias task via CANTAB.

Time frame
Change from baseline at 12-weeks

Secondary outcomes

1

Cardiorespiratory fitness change

Cardiorespiratory fitness, measured via VO2max test.

Time frame
Change from baseline at 12-weeks
2

Cognitive performance: Psychomotor function

Reaction time, simple and multi-choice measured via CANTAB.

Time frame
Change from baseline at 12-weeks
3

Cognitive performance: Attention

Rapid Visual Information Processing, measured via CANTAB.

Time frame
Change from baseline at 12-weeks
4

Cognitive performance: Executive Function

Measured via One Touch stockings of Cambridge task, in CANTAB

Time frame
Change from baseline at 12-weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.