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Completed

NCT Number: NCT04078724

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

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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Key information

Conditions

Sleep Dyssomnias Gut Microbiome Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannah Seniors Activity Centre, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Without 5-HTP

Other

Subject will not take 5-HTP

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2019
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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