Impact of Nutritional Supplementation on Sleep Quality and Gut Microbiome Composition in Older Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-04

Study Completion Date

2021-06-30

Brief Summary

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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 impairment (MCI) using a randomized controlled trial.

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Detailed Description

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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 60-85y, approximately half men and half women, approximately half subjects with MCI) will be recruited with the expectation that ≥ 40 subjects (≥ 10 subjects per group) will complete the study. Body size, blood pressure, urinary melatonin, sleep quality, cognitive function and mood (including depression and anxiety), gut microbiome, and short chain fatty acids will be assessed. Blood amino acid concentration will be measured as an indicator of compliance to the 5-HTP consumption from the collected blood samples.

Relevance to Singapore: The results from the proposed research will assist a practical guidance of nutritional behavior changes providing gut and brain health promoting effects to Singapore older individuals with or without MCI and may result in reducing cost and manpower for cognitive decline care.

Conditions

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Sleep Gut Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Normal subject without 5-HTP

Subjects with normal cognition will be randomly assigned to not consuming 5-HTP.

Group Type ACTIVE_COMPARATOR

Without 5-HTP

Intervention Type OTHER

Subject will not take 5-HTP

Normal subject with 5-HTP

Subjects with normal cognition will be randomly assigned to consuming 100 mg of 5-HTP.

Group Type EXPERIMENTAL

5-HTP

Intervention Type DIETARY_SUPPLEMENT

5-HTP that have Good Manufacturing Practice certification will be used and participants will be suggested to be take the 5-HTP supplementation at bedtime.

Interventions

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5-HTP

5-HTP that have Good Manufacturing Practice certification will be used and participants will be suggested to be take the 5-HTP supplementation at bedtime.

Intervention Type DIETARY_SUPPLEMENT

Without 5-HTP

Subject will not take 5-HTP

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Able to give an informed consent
2. Age 60 ≤years ≤ 85 years old
3. Weight change \< 3kg in the past 3 months
4. Not exercising vigorously over the past 3 months
5. Not taking protein (e.g. Whey isolate, Ensure), tryptophan, serotonin and/or 5-HTP supplements for the past one month
6. Not taking sleep medication and/or dietary supplements for sleep (e.g. melatonin, GABA) for the past one month
7. Not taking prebiotic, probiotic and/or dietary fiber supplementations for the past one month
8. Not taking cognitive/brain supplementations (e.g. gingko biloba, acetylcholine) for the past one month
9. Not taking prescription anti-depressant or pain medication (e.g. Zoloft, Tramadol etc.)
10. No acute illness
11. 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
12. Not smoking
13. Not drinking more than 2 alcoholic drinks per day

Exclusion Criteria

1. Unable to give an informed consent
2. Age \< 60 years and \>85 years old
3. Weight change \>3kg in the past 3 months
4. Exercises vigorously over the past 3 months
5. Taking protein (e.g. Whey isolate, Ensure), tryptophan, serotonin and/or 5-HTP supplements for the past one month
6. Taking sleep medication and/or dietary supplements for sleep (e.g. melatonin, GABA) for the past one month
7. Taking prebiotic, probiotic and/or dietary fiber supplementations for the past one month
8. Taking cognitive/brain supplementation (e.g. gingko biloba, acetylcholine) for the past one month
9. Taking prescription anti-depressant or pain medication (e.g. Zoloft, Tramadol etc.)
10. Having acute illness
11. 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
12. Smoking
13. Drinking more than 2 alcoholic drinks/day

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes