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

National University of Singapore33 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Sleep Gut Microbiome

Interventions

5-HTPDIETARY_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.

Without 5-HTPOTHER

Subject will not take 5-HTP

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

National University of Singapore

Singapore, Singapore

Hannah Seniors Activity Centre

Singapore, Singapore

Outcomes

Primary Outcomes

Change in sleep quality assessed by validated sleep questionnaires

Pittsburgh Sleep Quality Index Questionnaire (PSQI) will be used to assess the sleep quality. Overall score ranging from 0 to 21 points, where lower scores denote a healthier sleep quality.

Time frame: Every 4 weeks (week 0, week 4, week 8 and week 12)

Change in sleep quality assessed by electronic equipment

An electronic equipment, actigraphy, will be used to assess the sleep quality, including sleep timing and wake up timing.

Time frame: Every 4 weeks (week 0, week 4, week 8 and week 12)

Change in fecal short chain fatty acid (SCFA) concentration as assessed by micromoles per gram (μmol/g)

Fecal SCFA concentration will be measured using gas chromatograph (GC) and assessed by μmol/g. There is no recognized range. Normally the higher level is better.

Time frame: Pre- and post-intervention (week 0 and week 12)

Change in fecal microbiome composition

High-throughput sequencing method (using Illumina MiSeq platforms) will be used to assess the changes in gut microbiome composition.

Time frame: Pre- and post-intervention (week 0 and week 12)

Secondary Outcomes

Change in Quality of Life: WHOQOL

The World Health Organization Quality of Life Assessment (WHOQOL) will be used to assess the quality of life. Score ranging from 0 to 100 points, where higher scores denote higher quality of life.

Time frame: Every 4 weeks (week 0, week 4, week 8 and week 12)

Change in Cognitive function

Montreal Cognitive Assessment (MOCA) will be used to assess the cognitive function. Score ranging from 0 to 30 points. A final total score of 26 and above is considered normal.

Data from ClinicalTrials.gov

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