Actively Recruiting

Phase Not Applicable
Age: 18Years - 59Years
All Genders
NCT06398496

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

Led by University College Cork · Updated on 2024-11-08

40

Participants Needed

1

Research Sites

124 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 59Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be able to give written informed consent.
  • Be between 18 and 59 years of age.
  • Be in generally good health except for Major Depressive Disorder.
  • Live in the community with a current diagnosis of Major Depressive Disorder and have a depression score of 13-31 on Beck's Depression Inventory-II.
Not Eligible

You will not qualify if you...

  • Changed pharmacological therapy less than 2 weeks before study start.
  • Have significant acute or chronic illnesses including cardiovascular, gastrointestinal (including functional GI disorders, inflammatory bowel disease, celiac disease), immunological, psychiatric (bipolar disorder, schizophrenia, psychosis), neurodevelopmental or neurodegenerative, metabolic disorders (including type I or II diabetes), or conditions preventing safe participation in moderate exercise.
  • Have malignant disease or end-stage organ disease.
  • Taking medications that interfere with study objectives or pose safety risks (e.g., anti-inflammatory drugs, corticosteroids, laxatives, enemas, proton-pump inhibitors, antibiotics, probiotics within 1 month, anti-coagulants, thrombocyte-aggregation blockers, or non-steroidal analgesics) without a 4-week washout.
  • Considered unlikely to comply with trial or poor attendance by investigator.
  • Currently receiving experimental drug treatments or participated in an experimental trial within 30 days.
  • Meeting national physical activity guidelines for structured aerobic exercise.
  • Females currently perimenopausal, menopausal, or post-menopausal.
  • Pregnant, planning pregnancy during study, or lactating females.
  • Not fluent in English or English is not first language.
  • Color blind.
  • Have dyslexia or dyscalculia.
  • Current habitual daily smoker.
  • Regular illegal drug use.
  • Alcohol abuse disorder.
  • Acute suicidality or suicide attempt in past 6 months.
  • Current eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder).

AI-Screening

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Trial Site Locations

Total: 1 location

1

University College Cork, APC Microbiome Ireland

Cork, Cork County, Ireland

Actively Recruiting

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Research Team

M

Move4Mood Study Recruitment

CONTACT

N

Nathan D Nuzum, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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