Clinical trial NCT04078724: Impact of Nutritional Supplementation on Sleep Quality and Gut Microbiome Composition in Older Adults
Official title: Impact of Nutritional Supplementation on Gut-brain Axis in Older Adults With Normal Cognition vs. Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Gut Microbiome
Keywords: Nutritional supplementation
Sleep quality
Cognitive function
Gut microbiome
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 33
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sleep quality assessed by validated sleep questionnaires
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Change in sleep quality assessed by electronic equipment
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Change in fecal short chain fatty acid (SCFA) concentration as assessed by micromoles per gram (μmol/g)
timeFrame: Pre- and post-intervention (week 0 and week 12)
measure: Change in fecal microbiome composition
timeFrame: Pre- and post-intervention (week 0 and week 12)
Secondary outcomes:
measure: Change in Quality of Life: WHOQOL
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Change in Cognitive function
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Change in mood (depression)
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Change in mood (anxiety)
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Change in urinary melatonin levels as assessed by nanogram per milliliter (ng/mL)
timeFrame: Pre- and post-intervention (week 0 and week 12)
measure: Change in blood amino acids assessed by nanomole per milliliter (ng/mL)
timeFrame: Pre- and post-intervention (week 0 and week 12)
measure: Change in weight and height
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Change in waist circumference as assessed by centimeter (cm)
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Dietary assessment
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
measure: Blood pressure as assessed by millimeter of mercury (mmHg)
timeFrame: Every 4 weeks (week 0, week 4, week 8 and week 12)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
city: Singapore
country: Singapore
facility: Hannah Seniors Activity Centre
Study officials:
affiliation: National University of Singapore
name: Kim J Eun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.