Status:
COMPLETED
Impact of Nutritional Supplementation on Sleep Quality and Gut Microbiome Composition in Older Adults
Lead Sponsor:
National University of Singapore
Conditions:
Sleep
Gut Microbiome
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief Summary
The aim of this study is to assess the impact of 5-hydroxytryptophan (5-HTP) supplementation on sleep quality and gut microbiome composition in older adults with normal cognition vs. mild cognitive im...
Detailed Description
This is a 12-wk parallel, single-bind (investigator), prospective study design with subjects randomly assigned to consume 100 mg of 5-HTP or does not consume 5-HTP. Fifty older men and women (aged 60-...
Eligibility Criteria
Inclusion
- Able to give an informed consent
- Age 60 ≤years ≤ 85 years old
- Weight change \< 3kg in the past 3 months
- Not exercising vigorously over the past 3 months
- Not taking protein (e.g. Whey isolate, Ensure), tryptophan, serotonin and/or 5-HTP supplements for the past one month
- Not taking sleep medication and/or dietary supplements for sleep (e.g. melatonin, GABA) for the past one month
- Not taking prebiotic, probiotic and/or dietary fiber supplementations for the past one month
- Not taking cognitive/brain supplementations (e.g. gingko biloba, acetylcholine) for the past one month
- Not taking prescription anti-depressant or pain medication (e.g. Zoloft, Tramadol etc.)
- No acute illness
- If taking antihypertensive/cholesterol-lowering/ type 2 diabetic medication, he/she has been taking the medication for more than 5 years prior to the study participation
- Not smoking
- Not drinking more than 2 alcoholic drinks per day
Exclusion
- Unable to give an informed consent
- Age \< 60 years and \>85 years old
- Weight change \>3kg in the past 3 months
- Exercises vigorously over the past 3 months
- Taking protein (e.g. Whey isolate, Ensure), tryptophan, serotonin and/or 5-HTP supplements for the past one month
- Taking sleep medication and/or dietary supplements for sleep (e.g. melatonin, GABA) for the past one month
- Taking prebiotic, probiotic and/or dietary fiber supplementations for the past one month
- Taking cognitive/brain supplementation (e.g. gingko biloba, acetylcholine) for the past one month
- Taking prescription anti-depressant or pain medication (e.g. Zoloft, Tramadol etc.)
- Having acute illness
- If taking antihypertensive/cholesterol-lowering/ type 2 diabetic medication, he/she has NOT been taking the medication for less than 5 years prior to the study participation
- Smoking
- Drinking more than 2 alcoholic drinks/day
Key Trial Info
Start Date :
July 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04078724
Start Date
July 4 2020
End Date
June 30 2021
Last Update
September 8 2021
Active Locations (2)
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1
National University of Singapore
Singapore, Singapore, 117546
2
Hannah Seniors Activity Centre
Singapore, Singapore, 59002