Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398496
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-01
Brief Title:
The Effects of Exercise on Gut Bacteria Mood and Cognition in Depression
Sponsor:
University College Cork
Organization:
University College Cork
Study Overview
Official Title:
Investigating the Effects of an Exercise Intervention on Gut Bacteria Mood and Cognition in Individuals With Major Depressive Disorder
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Move4Mood
Brief 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
Measurements taken before during and following the 12-week intervention will include assessments of cognition cardiorespiratory fitness stress mood and emotion and gut bacteria
Detailed Description:
Major depressive disorder MDD affects 10 of people globally Additionally approximately only half of individuals respond to current psychotherapy treatments with approximately 30 of individuals classed as treatment resistant to psychopharmacological treatments Despite the current variety in treatments the gap in efficacy of current treatments means it is imperative to develop a deeper understanding of MDD so additional treatment options are available to help those whose current treatment is ineffective Apart from psychotherapies or combined psychopharmacotherapies exercise may be beneficial for individuals with MDD
The microbiota-gut-brain-axis has been implicated in MDD with gut bacteria relative abundance differences observed between individuals with MDD and healthy controls Exercise interventions can reduce depressive symptoms in individuals with mild-moderate MDD and may be beneficial to people alongside standard care Physical activity is also capable of modulating the gut microbiome However it remains an open question if lifestyle interventions such as exercise may act through the microbiome to enact positive outcomes in individuals with MDD
As depression does not affect brain function exclusively but manifests as a whole-body disorder the investigators propose that depression is in part a disorder of the microbiome-gut-brain-axis Given that the gut microbiome is capable of driving stress and immune alterations that regulate dysfunctional brain circuitry contributing to depressive symptomology including cognitive dysfunction and negative biases Therefore the current project will be the first to assess the gut microbiome in MDD whilst undergoing an exercise intervention in conjunction with monitoring dietary intakes
To achieve this a RCT will be conducted with two groups of adults with MDD randomized to either a control usualstandard care or exercise intervention aerobic exercise usualstandard care The intervention period will last 12-weeks with those in the exercise group receiving an aerobic exercise program tailored via progressive overload to get them to meet and then exceed the national physical activity guidelines 150min of moderate activity per week by the 12-week mark Each group will be assessed pre- mid- and post-intervention for depressive symptoms cognition negative biases along with diet information with mechanistic insights gained from evaluation of gut microbiome composition and function and gut metabolites in the context of microbiota-gut-brain axis signaling
Prior to enrollment participants will be informed about the study via a participant information leaflet and any participant who provides written informed consent to their participation in the study will then be screened for eligibility and enrolled if eligible
The microbiota-gut-brain-axis has been implicated in MDD with gut bacteria relative abundance differences observed between individuals with MDD and healthy controls Exercise interventions can reduce depressive symptoms in individuals with mild-moderate MDD and may be beneficial to people alongside standard care Physical activity is also capable of modulating the gut microbiome However it remains an open question if lifestyle interventions such as exercise may act through the microbiome to enact positive outcomes in individuals with MDD
As depression does not affect brain function exclusively but manifests as a whole-body disorder the investigators propose that depression is in part a disorder of the microbiome-gut-brain-axis Given that the gut microbiome is capable of driving stress and immune alterations that regulate dysfunctional brain circuitry contributing to depressive symptomology including cognitive dysfunction and negative biases Therefore the current project will be the first to assess the gut microbiome in MDD whilst undergoing an exercise intervention in conjunction with monitoring dietary intakes
To achieve this a RCT will be conducted with two groups of adults with MDD randomized to either a control usualstandard care or exercise intervention aerobic exercise usualstandard care The intervention period will last 12-weeks with those in the exercise group receiving an aerobic exercise program tailored via progressive overload to get them to meet and then exceed the national physical activity guidelines 150min of moderate activity per week by the 12-week mark Each group will be assessed pre- mid- and post-intervention for depressive symptoms cognition negative biases along with diet information with mechanistic insights gained from evaluation of gut microbiome composition and function and gut metabolites in the context of microbiota-gut-brain axis signaling
Prior to enrollment participants will be informed about the study via a participant information leaflet and any participant who provides written informed consent to their participation in the study will then be screened for eligibility and enrolled if eligible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None