Status:
COMPLETED
The Impact of Exercise on Hippocampus-dependent Cognition and the Gut Microbiota
Lead Sponsor:
King's College London
Collaborating Sponsors:
Reta Lila Weston Trust
University College Cork
Conditions:
Cognitive Decline
Eligibility:
All Genders
45-65 years
Phase:
NA
Brief Summary
The NeuroFit study will be investigating the impact of exercise on global cognition, hippocampus-dependent memory function and the gut microbiota in a middle-aged population.
Detailed Description
Main research question: Does exercise have an impact on global cognition, hippocampus-dependent memory function and the gut microbiota in a middle-aged human population? Middle-age is a critical time...
Eligibility Criteria
Inclusion
- 45 - 65 years of age.
- BMI 20 - 30.
- Does less than 90 minutes of moderate to vigorous physical activity per week and does not have a regular exercise routine(captured by self-reported measures)
Exclusion
- Subject is unable to understand the participant information sheet.
- Subject is unable to provide written informed consent.
- Subject is unable to understand and/or completely perform the cognitive testing.
- Impaired vision that is not corrected.
- Subject is a smoker.
- Does not agree to maintain their habitual dietary routine.
- Unwilling to provide blood and stool samples.
- Is not in general good health on the basis of medical history.
- Unable to engage in a structured exercise program as determined by the physical activity readiness questionnaire (PARQ).
- Unwilling to engage in the prescribed exercise program 3 times a week.
- Subject is pregnant, lactating or planning pregnancy.
- Recent history (previous 2 years) or currently diagnosed with a significant psychiatric disorder including major depressive disorder, anxiety, bipolar disorder, schizophrenia or any other Diagnostic Statistical Manual (DSM)-IV Axis I disorder.
- Subject has significant acute or chronic co-existing cardiovascular, respiratory, gastrointestinal illness or liver disease.
- Subject has had major GI surgery including bariatric surgery (excluding appendectomy and cholecystectomy).
- History of cancer in the last 5 years (excluding melanoma).
- Subject has significantly out of range blood test results from screening visit.
- History of or currently diagnosed with a functional GI disorder including inflammatory bowel disease (including Crohn's disease and ulcerative colitis), coeliac disease, lactose intolerance and clinical diagnosis of irritable bowel syndrome.
- Subject has irritable bowel syndrome, functional diarrhoea or functional constipation as determined by the Rome IV.
- Subject has any neurological disorder that could produce cognitive deterioration including Alzheimer's disease, Parkinson's disease, and stroke.
- Subject has a neurodevelopmental disorder that impacts ability to take part in cognitive testing and/or memory function.
- History of traumatic brain injury, stroke or any other medical conditions causing cognitive impairment.
- Subject has uncontrolled epilepsy or is prone to fainting.
- Subject has an eating disorder.
- History of or currently diagnosed with a metabolic disorder including type 1 and type 2 diabetes mellitus.
- Subject is unwilling to stop taking prebiotics or probiotics for at least 4 weeks prior to commencing the study.
- Known or suspected of alcohol abuse defined as \> 14 drinks per week (1 drink = 1 pint of beer, 1 large glass of wine or 50 ml spirit).
- Subject has a sleep disorder or an occupation where sleep during the overnight hours is irregular.
- Subjects routinely taking psychoactive medications, laxatives, enemas, antibiotics, anticoagulants, NSAIDs, proton pump inhibitors and unwilling to stop at least 4 weeks prior to commencing the study.
- Subjects taking the following prescription medications: Statins, Metformin, Donepezil (Aricept), Galantamine (Reminyl), Rivastigmine (Exelon), Tacrine (Cognex), Memantine (Namenda), Selegiline (Eldepryl) or any other medication for cognitive impairment.
- Subject has a condition the chief investigator believes would interfere with their ability to provide informed consent, comply with the study protocol, may confound the interpretation of study results, or put the subject at undue risk.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05397990
Start Date
March 1 2022
End Date
November 18 2024
Last Update
January 7 2026
Active Locations (1)
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1
Curie Kim
London, London, United Kingdom, SE5 8AZ