Status:
COMPLETED
Intermittent Energy Restriction and Chewing on Neural Stem Cell Ageing and Adult Hippocampal Neurogenesis Associated Cognition
Lead Sponsor:
King's College London
Collaborating Sponsors:
Medical Research Council
Mars, Inc.
Conditions:
Aging
Cognitive Decline
Eligibility:
FEMALE
60+ years
Phase:
NA
Brief Summary
Extended bouts of periodic mastication and intermittent energy restriction (IER) may improve cognitive performance in the context of adult hippocampal neurogenesis in an ageing population. A randomise...
Detailed Description
Nutrition and human health are strongly related. Altering overabundance through fasting/calorie-restricted diets has profound effects on homeostasis, tissue regeneration, and cancer. Tissue stem cells...
Eligibility Criteria
Inclusion
- Male and female subjects.
- 60+ years of age at the time of consent.
- BMI 25-35.
Exclusion
- Subject is unable to understand the participant information sheet.
- Subject is unable to understand and/or completely perform the cognitive testing.
- Chews more than 3 sticks of gum per month, including nicotine replacement gum.
- Unable to provide written informed consent.
- Impaired vision that is not corrected.
- Does not agree to maintain their habitual exercise routine.
- Is not in general good health on the basis of medical history.
- Unwilling to chew gum for 3 times a day for 12 weeks.
- Unwilling to maintain an intermittent fasting diet regime.
- Unwilling to have blood taken.
- History of or are currently diagnosed with a significant psychiatric disorder (e.g. schizophrenia, anxiety, PTSD).
- Subject has any neurological disorder that could produce cognitive deterioration (e.g. Alzheimer's disease, Parkinson's disease, stroke).
- History of traumatic brain injury, stroke or any other medical conditions causing cognitive impairment.
- Has uncontrolled epilepsy or is prone to fainting.
- Participated in a weight management drug trial in previous 3 months.
- Has undergone bariatric surgery.
- Known or suspected of alcohol abuse defined as \>14 drinks per week (1 drink = 1 pint of beer, 1 large glass of wine or 50ml spirit).
- Gastrointestinal or liver disease.
- Subject has a sleep disorder or an occupation where sleep during the overnight hours is irregular.
- Subjects taking the following prescription medications: Donepezil (Aricept), Galantamine (Reminyl), Rivastigmine (Exelon), Tacrine (Cognex), Bethanechol (Urecholine), Memantine (Namenda) Selegiline (Eldepryl) or any other medication for cognitive impairment.
- Subject has a known sensitivity to the study product.
- Individual has a condition the chief investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, might confound the interpretation of study results or put the subject at undue risk.
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT03457870
Start Date
April 18 2018
End Date
March 23 2020
Last Update
February 18 2021
Active Locations (1)
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1
Diabetes & Nutritional Sciences Division, King's College London, Franklin-Wilkins Building, 150 Stamford St
London, England, United Kingdom, SE1 9NH