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

NCT04078724 | Completed

• 1 other identifier: S8
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep; Gut Microbiome

Keywords

Nutritional supplementation; Sleep quality; Cognitive function; Gut microbiome

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Pre- and post-intervention (week 0 and week 12)

Secondary Outcomes (10)

• Change in Quality of Life: WHOQOL

  Every 4 weeks (week 0, week 4, week 8 and week 12)

• Change in Cognitive function

  Every 4 weeks (week 0, week 4, week 8 and week 12)

• Change in mood (depression)

  Every 4 weeks (week 0, week 4, week 8 and week 12)

• Change in mood (anxiety)

  Every 4 weeks (week 0, week 4, week 8 and week 12)

• Change in urinary melatonin levels as assessed by nanogram per milliliter (ng/mL)

  Pre- and post-intervention (week 0 and week 12)

Study Arms (2)

Normal subject without 5-HTP

ACTIVE COMPARATOR

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

Other: Without 5-HTP

Normal subject with 5-HTP

EXPERIMENTAL

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

Dietary Supplement: 5-HTP

Interventions

5-HTP 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.

Normal subject with 5-HTP

Without 5-HTP OTHER

Subject will not take 5-HTP

Normal subject without 5-HTP

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (2)

National University of Singapore

Singapore, 117546, Singapore

Location

Hannah Seniors Activity Centre

Singapore, 59002, Singapore

Location

Related Publications (3)

• Mohajeri MH, Wittwer J, Vargas K, Hogan E, Holmes A, Rogers PJ, Goralczyk R, Gibson EL. Chronic treatment with a tryptophan-rich protein hydrolysate improves emotional processing, mental energy levels and reaction time in middle-aged women. Br J Nutr. 2015 Jan 28;113(2):350-65. doi: 10.1017/S0007114514003754. Epub 2015 Jan 9.

  PMID: 25572038 BACKGROUND

• Anderson JR, Carroll I, Azcarate-Peril MA, Rochette AD, Heinberg LJ, Peat C, Steffen K, Manderino LM, Mitchell J, Gunstad J. A preliminary examination of gut microbiota, sleep, and cognitive flexibility in healthy older adults. Sleep Med. 2017 Oct;38:104-107. doi: 10.1016/j.sleep.2017.07.018. Epub 2017 Aug 2.

  PMID: 29031742 RESULT

• Sutanto CN, Xia X, Heng CW, Tan YS, Lee DPS, Fam J, Kim JE. The impact of 5-hydroxytryptophan supplementation on sleep quality and gut microbiota composition in older adults: A randomized controlled trial. Clin Nutr. 2024 Mar;43(3):593-602. doi: 10.1016/j.clnu.2024.01.010. Epub 2024 Jan 17.

  PMID: 38309227 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

5-Hydroxytryptophan

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptophan; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Kim J Eun, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: September 6, 2019
• Study Start: July 4, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)