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

August 31, 2021 updated by: Jung Eun Kim, National University, Singapore

Impact of Nutritional Supplementation on Gut-brain Axis in Older Adults With Normal Cognition vs. Mild Cognitive Impairment

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117546
        • National University of Singapore
      • Singapore, Singapore, 59002
        • Hannah Seniors Activity Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Normal subject without 5-HTP
Subjects with normal cognition will be randomly assigned to not consuming 5-HTP.
Other: Without 5-HTP
Subject will not take 5-HTP
EXPERIMENTAL: Normal subject with 5-HTP
Subjects with normal cognition will be randomly assigned to consuming 100 mg of 5-HTP.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep quality assessed by validated sleep questionnaires
Time Frame: 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.
Every 4 weeks (week 0, week 4, week 8 and week 12)
Change in sleep quality assessed by electronic equipment
Time Frame: 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.
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)
Time Frame: 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.
Pre- and post-intervention (week 0 and week 12)
Change in fecal microbiome composition
Time Frame: 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.
Pre- and post-intervention (week 0 and week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life: WHOQOL
Time Frame: 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.
Every 4 weeks (week 0, week 4, week 8 and week 12)
Change in Cognitive function
Time Frame: 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.
Every 4 weeks (week 0, week 4, week 8 and week 12)
Change in mood (depression)
Time Frame: 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.
Every 4 weeks (week 0, week 4, week 8 and week 12)
Change in mood (anxiety)
Time Frame: 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.
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)
Time Frame: 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.
Pre- and post-intervention (week 0 and week 12)
Change in blood amino acids assessed by nanomole per milliliter (ng/mL)
Time Frame: 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.
Pre- and post-intervention (week 0 and week 12)
Change in weight and height
Time Frame: 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.
Every 4 weeks (week 0, week 4, week 8 and week 12)
Change in waist circumference as assessed by centimeter (cm)
Time Frame: 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.
Every 4 weeks (week 0, week 4, week 8 and week 12)
Dietary assessment
Time Frame: Every 4 weeks (week 0, week 4, week 8 and week 12)
Dietary assessment will be assessed by 3-day dietary food record.
Every 4 weeks (week 0, week 4, week 8 and week 12)
Blood pressure as assessed by millimeter of mercury (mmHg)
Time Frame: 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.
Every 4 weeks (week 0, week 4, week 8 and week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University, Singapore

Investigators

  • Principal Investigator: Kim J Eun, PhD, National University, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 4, 2020

Primary Completion (ACTUAL)

June 30, 2021

Study Completion (ACTUAL)

June 30, 2021

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (ACTUAL)

September 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Electronic copies of the data with identifiable participant information will be kept on a secure website with access limited to Dr. Kim and her research staff. All data will be de-identified prior to statistical analyses

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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