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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078724
• Other study ID #: S8
• Status: Completed
• Phase: N/A
• Start date: July 4, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gut Microbiome
• Sleep

Intervention

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.

Other:
• Without 5-HTP
Subject will not take 5-HTP

Locations

Country	Name	City	State
Singapore	Hannah Seniors Activity Centre	Singapore
Singapore	National University of Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

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- — View 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. — View Citation

Outcome

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