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

Not Applicable

Completed

• Conditions: Sleep; Gut Microbiome
• Interventions: Dietary Supplement: 5-HTP; Other: Without 5-HTP

• Registration Number: NCT04078724
• Lead Sponsor: National University of Singapore

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 impairment (MCI) using a randomized controlled trial.

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 60-85y, 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 Timeline

• Study First Submitted: 2019-08-22
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Study Start: 2020-07-04
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal subject with 5-HTP	5-HTP	Subjects with normal cognition will be randomly assigned to consuming 100 mg of 5-HTP.
Normal subject without 5-HTP	Without 5-HTP	Subjects with normal cognition will be randomly assigned to not consuming 5-HTP.

Primary Outcome Measures

Name	Time	Method
Change in sleep quality assessed by validated sleep questionnaires	Every 4 weeks (week 0, week 4, week 8 and week 12)	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.
Change in sleep quality assessed by electronic equipment	Every 4 weeks (week 0, week 4, week 8 and week 12)	An electronic equipment, actigraphy, will be used to assess the sleep quality, including sleep timing and wake up timing.
Change in fecal short chain fatty acid (SCFA) concentration as assessed by micromoles per gram (μmol/g)	Pre- and post-intervention (week 0 and week 12)	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.
Change in fecal microbiome composition	Pre- and post-intervention (week 0 and week 12)	High-throughput sequencing method (using Illumina MiSeq platforms) will be used to assess the changes in gut microbiome composition.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life: WHOQOL	Every 4 weeks (week 0, week 4, week 8 and week 12)	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.
Change in Cognitive function	Every 4 weeks (week 0, week 4, week 8 and week 12)	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.
Change in mood (depression)	Every 4 weeks (week 0, week 4, week 8 and week 12)	Geriatric Depression Scale (GDS) Assessment will be used to assess the depression situation. Score ranging from 0 to 15 points. Although differing sensitivities and specificities have been obtained across studies, for clinical purposes a score \> 5 points is suggestive of depression and should warrant a follow-up interview. Scores \> 10 are almost always depression.
Change in weight and height	Every 4 weeks (week 0, week 4, week 8 and week 12)	Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m\^2.
Change in waist circumference as assessed by centimeter (cm)	Every 4 weeks (week 0, week 4, week 8 and week 12)	Recommended cutoffs for increased health risk are a waist circumference \>102 cm for men and \>88 cm for women.
Change in mood (anxiety)	Every 4 weeks (week 0, week 4, week 8 and week 12)	Geriatric Anxiety Inventory (GAI) Assessment will be used to assess the anxiety situation. Score ranging from 0 to 20 points, where higher scores denote higher level of anxiety.
Change in urinary melatonin levels as assessed by nanogram per milliliter (ng/mL)	Pre- and post-intervention (week 0 and week 12)	Change in urinary melatonin levels will be assessed by using enzyme linked immunosorbent assay (ELISA) kits. There is no recognized range. Normally the higher level is better.
Change in blood amino acids assessed by nanomole per milliliter (ng/mL)	Pre- and post-intervention (week 0 and week 12)	Amino Acid Analysis System will be used to assess the blood amino acid levels. There is no recognized range.
Dietary assessment	Every 4 weeks (week 0, week 4, week 8 and week 12)	Dietary assessment will be assessed by 3-day dietary food record.
Blood pressure as assessed by millimeter of mercury (mmHg)	Every 4 weeks (week 0, week 4, week 8 and week 12)	Systolic and diastolic blood pressure will be measured by a blood pressure monitor. For a normal reading, systolic pressure is between 90 and 120 and diastolic pressure is between 60 and 80.

Trial Locations

Locations (2)

Hannah Seniors Activity Centre; 🇸🇬 Singapore, Singapore

National University of Singapore; 🇸🇬 Singapore, Singapore