SleepNCT05400005
Impact of Different Types of Higher Dietary Protein Intake on Sleep Quality in Singapore Older Adults
A study testing Dietary protein in people with Sleep and Gut Microbiome, run by National University of Singapore at 1 site in Singapore.
Trial summary
Today, insufficient sleep has become a growing global problem. Sleep is essential to health and changes in sleep patterns are a part of the aging process. Inadequate and low-quality sleep also increases the risk for age-related cognitive decline and disease conditions. 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, Cardiometabolic Risk
- What is being tested?
- Dietary protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Feb 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults 60-85 years old
- Not following HPB diet
Who cannot join
- Weight change > 3kg in the past 3 months
- Exercise vigorously over the past 3 months
- Drinking more than 2 alcoholic drinks per day
- (if applicable) Pre-menopausal women
- Taking dietary supplements or medications which may impact sleep outcomes (e.g. Nutritional Shakes (e.g. Ensure), Trp, 5-HTP or melatonin supplementations) the past 1 month
- Taking dietary supplements which may impact the gut microbiota (e.g. antibiotics, prebiotics, probiotics) the past 2 months (a list of fermented foods)
Show all 10Show fewer
- Impaired renal function (normal values: estimated glomerular filtration rate ≥ 90 mL/min/1.73 m2 calculated by chronic kidney disease epidemiology collaboration equation; CKD EPI)
- Soy intolerance and/or allergy or any medical conditions that may be affected by consumption of soy products (e.g. gout)
- Prescribed and taking antihypertensive/cholesterol-lowering/ type-2 diabetic medication or Chinese medicine herb which started less than 3 years prior to the intervention participation
- Diagnosed with gut/gastrointestinal issues such as lactose intolerance and irritable bowel syndrome (IBS)
Trial locations and contacts
1 site in 1 country.
About this study
Today, insufficient sleep has become a growing global problem. Sleep is essential to health and changes in sleep patterns are a part of the aging process. Inadequate and low-quality sleep also increases the risk for age-related cognitive decline and disease conditions. More importantly, due to COVID-19 health emergency, there is a significant increase of psychological distress and symptoms of mental illness and a worsening of quality of sleep. Therefore, there is an urgent need to investigate the way of improving sleep quality, in particular during and post COVID-19 period, in older adults.
One of the possible strategies in improving sleep quality with lifestyle modification is having higher-protein diet. However, this effect has not been fully elucidated in older adults. In addition, the effect of type of dietary protein on sleep quality is inconclusive and there is no clinical trial which assessed the differential response in sleep quality between animal-sourced protein vs. plant-sourced protein. Therefore, the purpose of this research project is to assess the impact of different types of higher dietary protein intake on sleep quality in Singapore older adults.
Findings from the proposed research will provide the scientific evidence of the beneficial effects of regularly consuming higher-protein diet on sleep quality in Singapore older adults. In addition, this research may validate the differential effect of different type of dietary protein on sleep quality. The results from the proposed research will also assist a practical guidance of nutritional behaviour changes providing sleep promoting effects to a large proportion of the Singapore population.
Read the detailed description
During the 16-week intervention, subjects will be randomly assigned to 1 of 3 groups including consuming normal-protein diet, higher-protein diet supplemented with micellar casein protein or higher-protein diet supplemented with soy protein. Recommended Dietary Allowances for healthy Singaporean. Normal-protein diet will be designed following a healthy eating pattern diet, referred to as the "My Healthy Plate" launched by Health Promotion Board and subjects will consume 3 servings of dietary protein. Higher-protein diet will also follow a healthy eating pattern diet while subjects will additionally take either 20 g micellar casein protein isolate or 20 g soy protein isolate. One-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff. Compliance with the diet interventions will be promoted by frequent online and in-person contact and dietary assessment. Blood amino acid concentration will also be assessed as an indicator of compliance to the protein intake.
- Conditions
- Sleep, Gut Microbiome, Cardiometabolic Risk
- Being tested
- Dietary protein
- Keywords
- Dietary protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary proteinOther
Intervention of the study include consuming a higher protein diet. Depending on the group allocation, this is done by asking the subjects to follow "My Healthy Plate" diet and consumption of 20g of protein isolates (casein or soy).
| Study group | Role | What they receive |
|---|---|---|
| Normal protein diet (control) | No intervention | Subjects are to consume normal-protein diet based on the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) for the duration of the 16-week study. |
| High protein diet (soy) | Experimental | Subjects are to consume higher-protein diet by following the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) and 20g of soy protein isolate for the duration of the 16-week study. Receives: Other: Dietary protein |
| High protein diet (Micellar Casein) | Experimental | Subjects are to consume higher-protein diet by following the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) and 20g of micellar casein isolate for the duration of the 16-week study. Receives: Other: Dietary protein |
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, week 12 and week 16)
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, week 12 and week 16)
Change in blood amino acid concentration
Amino acid concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in blood serotonin concentration
Serotonin concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in urinary 6-sulfatoxymelatonin (aMT6s) concentration
6-sulfatoxymelatonin (aMT6s) concentration in the urine samples will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Secondary outcomes (27)
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: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal short chain fatty acid (SCFA) concentration
SCFA concentration in fecal samples will be measured.
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in serum lipopolysaccharide binding protein (LBP) concentration
LBP concentration in blood samples will be measured.
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in blood short chain fatty acid (SCFA) concentration
SCFA concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal bile acids
Bile acids concentration will be determined from fecal samples of the subjects
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal zonulin
Zonulin concentration will be determined from fecal samples of the subjects
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal calprotectin
Calprotectin concentration will be determined from fecal samples of the subjects
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in urinary creatinine concentration
Creatinine concentration in the urine samples will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Estimated Glomerular Filtration Rate (eGFR)
The estimated Glomerular Filtration Rate (eGFR) of the subjects will be measured from the blood
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Trimethylamine N-oxide (TMAO)
Trimethylamine N-oxide (TMAO) concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Glucose
Glucose concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Triglyceride
Triglyceride concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Cholesterol
Total cholesterol concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Low-density Lipoprotein-cholesterol (LDL)
LDL concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood High-density Lipoprotein-cholesterol (LDL)
HDL concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Advanced Glycation End-product (AGEs)
AGEs concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Skin Advanced Glycation End-product (AGEs)
Using a scanner, the AGEs levels in the skin will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Interleukin-6 (IL-6)
Interleukin-6 (IL-6) concentration in the blood will be measured
Measured: Every 8 weeks (week 0 , week 8 and week 16)
Change in Endothelial Function
Endothelial functions are determined by the function of endothelial progenitor cells
Measured: Baseline and Post-intervention (week 0 and week 16)
Change in Flow Mediate Dilation
Flow mediate dilation (%)
Measured: Baseline and Post-intervention (week 0 and week 16)
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, week 12 and week 16)
Change in waist circumference
Waist circumference (in cm) will be measured
Measured: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in blood pressure
Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Measured: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Dietary assessment
Dietary assessment will be assessed by 3-day dietary food record
Measured: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (stress)
Perceived Stress Scale (PSS) will be used to assess the stress levels
Measured: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (depression)
Geriatric Depression Scale (GDS) Assessment will be used to assess the depression status
Measured: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (anxiety)
Geriatric Anxiety Inventory (GAI) Assessment will be used to assess the anxiety status.
Measured: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Feb 2023
- Primary completion22 Oct 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Factorial
- Model description
- This is a 16-week factorial study design with subjects randomly assigned to consume normal-protein diet, higher-protein diet with micellar casein protein isolates or higher-protein diet with soy protein isolates. Subjects' sleep quality will also be evaluated and screened using the PSQI questionnaire (GSS ≤5 \[good sleepers\] vs. GSS \>5 \[poor sleepers\]). Sixty-eight older men and women (aged 60-85y, approximately half men and half women) will be recruited with the expectation that ≥ 54 subjects (≥ 18 subjects per group) will complete the study (≤ 20% dropout rate). The 18 subjects recruited for each of the intervention group were further classified into poor (n=9) and good sleepers (n=9).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
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
- Jung Eun Kim, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400005
- Sponsor's protocol ID
- S19
- Status last verified
- Sep 2025
- First submitted
- 27 May 2022
- Last updated
- 10 Sep 2025
- 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
Cappuccio FP, D'Elia L, Strazzullo P, Miller MA. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010 May;33(5):585-92. doi: 10.1093/sleep/33.5.585.
PubMed 20469800Sutanto CN, Wang MX, Tan D, Kim JE. Association of Sleep Quality and Macronutrient Distribution: A Systematic Review and Meta-Regression. Nutrients. 2020 Jan 2;12(1):126. doi: 10.3390/nu12010126.
PubMed 31906452Zhou J, Kim JE, Armstrong CL, Chen N, Campbell WW. Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials. Am J Clin Nutr. 2016 Mar;103(3):766-74. doi: 10.3945/ajcn.115.124669. Epub 2016 Feb 10.
PubMed 26864362Saidi O, Rochette E, Dore E, Maso F, Raoux J, Andrieux F, Fantini ML, Merlin E, Pereira B, Walrand S, Duche P. Randomized Double-Blind Controlled Trial on the Effect of Proteins with Different Tryptophan/Large Neutral Amino Acid Ratios on Sleep in Adolescents: The PROTMORPHEUS Study. Nutrients. 2020 Jun 24;12(6):1885. doi: 10.3390/nu12061885.
PubMed 32599773St-Onge MP, Crawford A, Aggarwal B. Plant-based diets: Reducing cardiovascular risk by improving sleep quality? Curr Sleep Med Rep. 2018 Mar;4(1):74-78. Epub 2018 Feb 5.
PubMed 29910998Ting M, Mak IEK, Yao Y, Chng ASM, Khoo CM, Kim JE. Investigating the Impact of Protein Supplementation from Different Sources on Advanced Glycation End Products in Older Adults in Singapore Following a Healthy Dietary Pattern. Nutrients. 2026 Sep 7;18(17):2925. doi: 10.3390/nu18172925.
PubMed 42739097Yao Y, Mak IE, Sutanto CN, Leong ZN, He Q, Pahwa U, Ling LH, Khoo CM, Ackers-Johnson MA, Foo RS, Kim JE. Impact of quantity and source of dietary protein intake within a healthy dietary pattern on cardiovascular disease risk factors in Singapore older adults: a randomized controlled trial. Food Funct. 2025 Dec 8;16(24):9533-9544. doi: 10.1039/d5fo03817k.
PubMed 41284351
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different Types of Higher Dietary Protein Intake on Sleep Quality in Singapore Older Adults
- ClinicalTrials.gov ID
- NCT05400005
- Acronym / sponsor ID
- S19
- Conditions
- Sleep, Gut Microbiome, Cardiometabolic Risk
- Keywords
- Dietary protein
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jun 2022 (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.
Today, insufficient sleep has become a growing global problem. Sleep is essential to health and changes in sleep patterns are a part of the aging process. Inadequate and low-quality sleep also increases the risk for age-related cognitive decline and disease conditions. More importantly, due to COVID-19 health emergency, there is a significant increase of psychological distress and symptoms of mental illness and a worsening of quality of sleep. Therefore, there is an urgent need to investigate the way of improving sleep quality, in particular during and post COVID-19 period, in older adults.
One of the possible strategies in improving sleep quality with lifestyle modification is having higher-protein diet. However, this effect has not been fully elucidated in older adults. In addition, the effect of type of dietary protein on sleep quality is inconclusive and there is no clinical trial which assessed the differential response in sleep quality between animal-sourced protein vs. plant-sourced protein. Therefore, the purpose of this research project is to assess the impact of different types of higher dietary protein intake on sleep quality in Singapore older adults.
Findings from the proposed research will provide the scientific evidence of the beneficial effects of regularly consuming higher-protein diet on sleep quality in Singapore older adults. In addition, this research may validate the differential effect of different type of dietary protein on sleep quality. The results from the proposed research will also assist a practical guidance of nutritional behaviour changes providing sleep promoting effects to a large proportion of the Singapore population.
Detailed description
During the 16-week intervention, subjects will be randomly assigned to 1 of 3 groups including consuming normal-protein diet, higher-protein diet supplemented with micellar casein protein or higher-protein diet supplemented with soy protein. Recommended Dietary Allowances for healthy Singaporean. Normal-protein diet will be designed following a healthy eating pattern diet, referred to as the "My Healthy Plate" launched by Health Promotion Board and subjects will consume 3 servings of dietary protein. Higher-protein diet will also follow a healthy eating pattern diet while subjects will additionally take either 20 g micellar casein protein isolate or 20 g soy protein isolate. One-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff. Compliance with the diet interventions will be promoted by frequent online and in-person contact and dietary assessment. Blood amino acid concentration will also be assessed as an indicator of compliance to the protein intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a 16-week factorial study design with subjects randomly assigned to consume normal-protein diet, higher-protein diet with micellar casein protein isolates or higher-protein diet with soy protein isolates. Subjects' sleep quality will also be evaluated and screened using the PSQI questionnaire (GSS ≤5 [good sleepers] vs. GSS >5 [poor sleepers]). Sixty-eight older men and women (aged 60-85y, approximately half men and half women) will be recruited with the expectation that ≥ 54 subjects (≥ 18 subjects per group) will complete the study (≤ 20% dropout rate). The 18 subjects recruited for each of the intervention group were further classified into poor (n=9) and good sleepers (n=9).
| Arm | Type | Receives |
|---|---|---|
| Normal protein diet (control) | No intervention | –Subjects are to consume normal-protein diet based on the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) for the duration of the 16-week study. |
| High protein diet (soy) | Experimental | Other: Dietary proteinSubjects are to consume higher-protein diet by following the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) and 20g of soy protein isolate for the duration of the 16-week study. |
| High protein diet (Micellar Casein) | Experimental | Other: Dietary proteinSubjects are to consume higher-protein diet by following the "My Healthy Plate" diet (launched by Health Promotion Board of Singapore) and 20g of micellar casein isolate for the duration of the 16-week study. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 60-85 years old
- Not following HPB diet
Key exclusion criteria (10 listed)
- Weight change > 3kg in the past 3 months
- Exercise vigorously over the past 3 months
- Drinking more than 2 alcoholic drinks per day
- (if applicable) Pre-menopausal women
- Taking dietary supplements or medications which may impact sleep outcomes (e.g. Nutritional Shakes (e.g. Ensure), Trp, 5-HTP or melatonin supplementations) the past 1 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 |
|---|---|---|
| Dietary proteinIntervention of the study include consuming a higher protein diet. Depending on the group allocation, this is done by asking the subjects to follow "My Healthy Plate" diet and consumption of 20g of protein isolates (casein or soy). | Other | High protein diet (Micellar Casein), High protein diet (soy) |
Primary outcome
Change in sleep quality assessed by validated sleep questionnaires
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
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, week 12 and week 16)
An electronic equipment, actigraphy, will be used to assess the sleep quality, including sleep timing and wake up timing.
Change in blood amino acid concentration
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Amino acid concentration in the blood will be measured
Change in blood serotonin concentration
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Serotonin concentration in the blood will be measured
Change in urinary 6-sulfatoxymelatonin (aMT6s) concentration
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
6-sulfatoxymelatonin (aMT6s) concentration in the urine samples will be measured
27 secondary outcomes
Change in fecal microbiome composition
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal short chain fatty acid (SCFA) concentration
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in serum lipopolysaccharide binding protein (LBP) concentration
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in blood short chain fatty acid (SCFA) concentration
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal bile acids
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal zonulin
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in fecal calprotectin
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in urinary creatinine concentration
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Trimethylamine N-oxide (TMAO)
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Glucose
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Triglyceride
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Cholesterol
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Low-density Lipoprotein-cholesterol (LDL)
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood High-density Lipoprotein-cholesterol (LDL)
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Advanced Glycation End-product (AGEs)
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Skin Advanced Glycation End-product (AGEs)
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Blood Interleukin-6 (IL-6)
Time frame: Every 8 weeks (week 0 , week 8 and week 16)
Change in Endothelial Function
Time frame: Baseline and Post-intervention (week 0 and week 16)
Change in Flow Mediate Dilation
Time frame: Baseline and Post-intervention (week 0 and week 16)
Change in weight and height
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in waist circumference
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in blood pressure
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Dietary assessment
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (stress)
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (depression)
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Change in mood (anxiety)
Time frame: Every 4 weeks (week 0, week 4, week 8, week 12 and week 16)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Background: PubMed 20469800Cappuccio FP, D'Elia L, Strazzullo P, Miller MA. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010 May;33(5):585-92. doi: 10.1093/sleep/33.5.585.
- Background: PubMed 31906452Sutanto CN, Wang MX, Tan D, Kim JE. Association of Sleep Quality and Macronutrient Distribution: A Systematic Review and Meta-Regression. Nutrients. 2020 Jan 2;12(1):126. doi: 10.3390/nu12010126.
- Background: PubMed 26864362Zhou J, Kim JE, Armstrong CL, Chen N, Campbell WW. Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials. Am J Clin Nutr. 2016 Mar;103(3):766-74. doi: 10.3945/ajcn.115.124669. Epub 2016 Feb 10.
- Background: PubMed 32599773Saidi O, Rochette E, Dore E, Maso F, Raoux J, Andrieux F, Fantini ML, Merlin E, Pereira B, Walrand S, Duche P. Randomized Double-Blind Controlled Trial on the Effect of Proteins with Different Tryptophan/Large Neutral Amino Acid Ratios on Sleep in Adolescents: The PROTMORPHEUS Study. Nutrients. 2020 Jun 24;12(6):1885. doi: 10.3390/nu12061885.
- Background: PubMed 29910998St-Onge MP, Crawford A, Aggarwal B. Plant-based diets: Reducing cardiovascular risk by improving sleep quality? Curr Sleep Med Rep. 2018 Mar;4(1):74-78. Epub 2018 Feb 5.
- Derived from this study: PubMed 42739097Ting M, Mak IEK, Yao Y, Chng ASM, Khoo CM, Kim JE. Investigating the Impact of Protein Supplementation from Different Sources on Advanced Glycation End Products in Older Adults in Singapore Following a Healthy Dietary Pattern. Nutrients. 2026 Sep 7;18(17):2925. doi: 10.3390/nu18172925.
- Derived from this study: PubMed 41284351Yao Y, Mak IE, Sutanto CN, Leong ZN, He Q, Pahwa U, Ling LH, Khoo CM, Ackers-Johnson MA, Foo RS, Kim JE. Impact of quantity and source of dietary protein intake within a healthy dietary pattern on cardiovascular disease risk factors in Singapore older adults: a randomized controlled trial. Food Funct. 2025 Dec 8;16(24):9533-9544. doi: 10.1039/d5fo03817k.
- 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.
Jung Eun Kim, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary protein in people with Sleep and Gut Microbiome, run by National University of Singapore at 1 site 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 2 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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, week 12 and week 16)). The study lists 5 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 NCT05400005, which also lists 7 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 10 Sep 2025.