SleepNCT04078724
Impact of Nutritional Supplementation on Sleep Quality and Gut Microbiome Composition in Older Adults
A study testing 5-HTP and Without 5-HTP in people with Sleep and Gut Microbiome, run by National University of Singapore at 2 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Gut Microbiome
- What is being tested?
- 5-HTP and Without 5-HTP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesSingapore
- Study dates
- 4 Jul 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University of Singapore
Singapore, 117546
Hannah Seniors Activity Centre
Singapore, 59002
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep, Gut Microbiome
- Being tested
- 5-HTP, Without 5-HTP
- Keywords
- Nutritional supplementation, Sleep quality, Cognitive function, Gut microbiome
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-HTPDietary 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-HTPOther
Subject will not take 5-HTP
| Study group | Role | What they receive |
|---|---|---|
| Normal subject without 5-HTP | Active comparator | Subjects with normal cognition will be randomly assigned to not consuming 5-HTP. Receives: 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. Receives: Dietary Supplement: 5-HTP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre- and post-intervention (week 0 and week 12)
Secondary outcomes (10)
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.
Measured: Every 4 weeks (week 0, week 4, week 8 and week 12)
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.
Measured: Every 4 weeks (week 0, week 4, week 8 and week 12)
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.
Measured: Every 4 weeks (week 0, week 4, week 8 and week 12)
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.
Measured: 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)
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.
Measured: Pre- and post-intervention (week 0 and week 12)
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.
Measured: Pre- and post-intervention (week 0 and week 12)
Change in weight and height
Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2.
Measured: Every 4 weeks (week 0, week 4, week 8 and week 12)
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.
Measured: Every 4 weeks (week 0, week 4, week 8 and week 12)
Dietary assessment
Dietary assessment will be assessed by 3-day dietary food record.
Measured: Every 4 weeks (week 0, week 4, week 8 and week 12)
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.
Measured: Every 4 weeks (week 0, week 4, week 8 and week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start4 Jul 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Eun Kim, National University of Singapore
- Investigators
- Kim J Eun, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078724
- Sponsor's protocol ID
- S8
- Status last verified
- Aug 2021
- First submitted
- 22 Aug 2019
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 25572038Anderson 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.
PubMed 29031742Sutanto 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.
PubMed 38309227
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Supplementation on Gut-brain Axis in Older Adults With Normal Cognition vs. Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04078724
- Acronym / sponsor ID
- S8
- Conditions
- Sleep, Gut Microbiome
- Keywords
- Nutritional supplementation, Sleep quality, Cognitive function, Gut microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 4 Jul 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal subject without 5-HTP | Active comparator | Other: Without 5-HTPSubjects with normal cognition will be randomly assigned to not consuming 5-HTP. |
| Normal subject with 5-HTP | Experimental | Dietary Supplement: 5-HTPSubjects with normal cognition will be randomly assigned to consuming 100 mg of 5-HTP. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-HTP5-HTP that have Good Manufacturing Practice certification will be used and participants will be suggested to be take the 5-HTP supplementation at bedtime. | Dietary supplement | Normal subject with 5-HTP |
| Without 5-HTPSubject will not take 5-HTP | Other | Normal subject without 5-HTP |
Primary outcome
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.
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.
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.
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.
10 secondary outcomes
Change in Quality of Life: WHOQOL
Time frame: 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)
Change in mood (depression)
Time frame: 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)
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 blood amino acids assessed by nanomole per milliliter (ng/mL)
Time frame: 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)
Change in waist circumference as assessed by centimeter (cm)
Time frame: 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)
Blood pressure as assessed by millimeter of mercury (mmHg)
Time frame: Every 4 weeks (week 0, week 4, week 8 and week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 25572038Mohajeri 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.
- Results publication: PubMed 29031742Anderson 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.
- Derived from this study: PubMed 38309227Sutanto 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.
- Individual participant dataSharing planned: No. 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
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kim J Eun, PhD principal investigator
National University of Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-HTP and Without 5-HTP in people with Sleep and Gut Microbiome, run by National University of Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep quality assessed by validated sleep questionnaires (time frame: Every 4 weeks (week 0, week 4, week 8 and week 12)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078724, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.