Cardiometabolic Risk FactorsNCT06775132
Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes
An observational study of Cardiometabolic Risk Factors and Skin Condition, run by National University of Singapore at 1 site in Singapore.
Trial summary
This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors, Skin Condition, Cognitive Ability, General
- How many people
- 240 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Feb 2025to 31 Dec 2026
- Phase
- Observational
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Singapore adults
Who may be able to join
- Able to give informed consent
- Adults 21-80 years old
- English-literate
- Have venous access sufficient to allow for blood sampling as per the protocol
- No drastic change of diet for the past 1 year
- If taking medication, has been consistently taking antihypertensive/cholesterol-lowering/type-2 diabetic medication for more than 5 years prior to starting the study.
Who cannot join
- Taking dietary supplements and fermented foods, which may impact the gut microbiota (e.g. antibiotics, prebiotics, probiotics, yogurt, kimchi) 2 months before starting the 1st study visit only.
- Taking dietary supplements or medications, which may impact sleep outcomes (e.g. Nutritional Shakes (e.g. Ensure), tryptophan, 5-hydroxytryptophan or melatonin supplementations) 1 month before starting the study.
- Taking dietary supplements which may impact the eye outcomes (e.g. Vitamin A, vitamin A-containing multivitamin) 2 months before starting the study.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
National University of Singapore
Singapore, Singapore, 117546
About this study
Official title: Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes in Singapore Adults
This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults.
Read the detailed description
Diet plays a crucial role in maintaining overall health, and changes in dietary patterns are increasingly recognized as major contributors to chronic disease development. Inadequate dietary intake and poor diet quality have been linked to increased risks of cardiometabolic diseases and disruptions in gut microbiota composition. However, most studies investigating these associations have been conducted on Western populations, and there is a lack of research focusing on Asian populations. Given the genetic, metabolic, and dietary differences between Western and Asian populations, examining these associations in an Asian population is essential for a deeper understanding of population-specific risk factors and health outcomes. Therefore, there is an urgent need to assess the associations between dietary intake, cardiometabolic health, and gut microbiota composition in Asian population.
This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults.
Findings from this study will offer valuable insights into the relationship between diet, cardiometabolic health, and the gut microbiota in this population. In addition, this research may identify specific dietary patterns or nutrients that offer greater benefit for cardiometabolic and gut health. In turn, these findings can contribute to the improvement of current dietary guidelines aimed at promoting better cardiometabolic and gut microbiota outcomes for the broader Singaporean population.
- Conditions
- Cardiometabolic Risk Factors, Skin Condition, Cognitive Ability, General, Sleep Quality, Gut-Microbiota
- Keywords
- Endothelial progenitor cells, Gut microbiota, Cardiovascular diseases risk factors, MoCA, Advanced glycation end products, Metabolomics
- Medical subject headings
- Skin Diseases, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Younger population | Age 21-64 | |
| Middle-aged and older population | Age 65-80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary intake
Use a 3-day food record to document dietary intake
Measured: Day 7
Blood pressure
Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Measured: Day 1
Blood lipid lipoprotein profile
Total cholesterol, LDL, HDL, and triglyceride concentration in the blood will be measured
Measured: Day 1
Fasting blood glucose
Glucose concentration in the blood will be measured
Measured: Day 1
Endothelial Progenitor Cell Count
Endothelial functions are determined by the percentage of endothelial progenitor cells (CD34+/KDR+) expression in peripheral blood mononuclear cells
Measured: Day 1
Fecal short chain fatty acid (SCFA) concentration
SCFA concentration in the blood will be measured
Measured: Day 1
Trimethylamine N-oxide (TMAO)
Trimethylamine N-oxide (TMAO) concentration in the blood will be measured
Measured: Day 1
Fecal bile acids
Bile acids concentration will be determined from fecal samples of the subjects
Measured: Day 1
Fecal zonulin
Zonulin concentration will be determined from fecal samples of the subjects
Measured: Day 1
Fecal calprotectin
Calprotectin concentration will be determined from fecal samples of the subjects
Measured: Day 1
Estimated Glomerular Filtration Rate (eGFR)
The estimated Glomerular Filtration Rate (eGFR) of the subjects will be measured from the blood
Measured: Day 1
Secondary outcomes (14)
Sleep quality-Pittsburgh Sleep Quality Index Questionnaire
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: Day 1
Cognitive function
Use Montreal Cognitive Assessment (MoCA) questionnaires to assess cognitive function. A score of 26 or above (out of 30) is generally considered normal, though adjustments may be made for educational level.
Measured: Day 1
Skin carotenoid concentration
Skin carotenoid concentration: This can be measured by Resonance Raman Spectroscopy, the unit is skin carotenoid score, a higher score means optimal, lower score means poor condition of skin carotenoids.
Measured: Day 1
Macular Pigment Optical Density (MPOD)
Macular Pigment Optical Density (MPOD): A measurement of macular pigment of the eye using a heterochromatic flicker photometry device. The measurements are in arbitrary units.
Measured: Day 1
The Global Physical Activity Questionnaire (GPAQ)
The Global Physical Activity Questionnaire (GPAQ) will be used to assess physical activity levels in three areas: work, transport, and leisure. It measures activity in terms of frequency, duration, and intensity, generating a score in metabolic equivalents (METs). Higher MET values indicate higher levels of physical activity.
Measured: Day 1
The Perceived Stress Scale (PSS-10)
The Perceived Stress Scale (PSS-10) will be used to assess the level of perceived stress over the past month. The scale consists of 10 items scored on a 5-point Likert scale (0 = never to 4 = very often), with a total score ranging from 0 to 40. Higher scores indicate greater perceived stress.
Measured: Day 1
The Beck Anxiety Inventory (BAI)
The Beck Anxiety Inventory (BAI) will be used to measure the severity of anxiety symptoms. It consists of 21 questions scored on a 4-point Likert scale (0 = not at all to 3 = severely). The total score ranges from 0 to 63, with higher scores reflecting more severe anxiety symptoms.
Measured: Day 1
The Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) will be used to assess the severity of depressive symptoms over the past two weeks. It contains 21 questions scored on a 4-point scale (0 = no symptoms to 3 = severe symptoms). Total scores range from 0 to 63, with higher scores indicating more severe depression.
Measured: Day 1
Visual acuity
Participants will read out letters on a ETDRS LogMAR chart at a fixed distance where letters becomes smaller as it goes down the chart. Tests results will be recorded in number of letters read, where the more letters the better the outcome.
Measured: Day 1
Visual function questionnaire 25
A questionnaire to for participants to self-evaluate their perception of their current eye health based on general vision, ocular pain, near activities, distance activities, vision specific functions, driving, color vision and peripheral vision. The best possible score is 100 and worst possible score is 0.
Measured: Day 1
Skin advanced glycation end products (AGE) levels
Skin advanced glycation end products (AGE) levels: Measurement of skin advanced glycation end products level using a skin autofluorescence device, where participants wlll be instructed to place their forearm over the device and a light will be shone and a reading can be captured by detecting fluorescence. The results will be presented as arbitrary units.
Measured: Day 1
Blood advanced glycation end products (AGE) levels
The blood drawn will be processed and stored. Measurements will be done using ultra-performance liquid chromatography coupled with mass spectrometry techniques to determine the levels of advanced glycation end products. Units will be in μg/mL.
Measured: Day 1
Contrast sensitivity
Participants will read out letters on a ETDRS LogMAR chart at a fixed distance, where the letters differs in lightness to test participants' sensitivity to contrast. Tests results will be recorded in number of letters read, where the more letters the better the outcome.
Measured: Day 1
Changes in metabolites found in plasma (plasma metabolomics)
Untargeted metabolomics profiling of plasma will be conducted using ultra performance liquid chromatography-quadrupole time of flight-mass spectrometry (UPLC-QTOF-MS)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start3 Feb 2025
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 240 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, Principal investigator, Department of Food Science and Technology, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775132
- Sponsor's protocol ID
- S27
- Status last verified
- Aug 2026
- First submitted
- 1 Jan 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes in Singapore Adults
- ClinicalTrials.gov ID
- NCT06775132
- Acronym / sponsor ID
- S27
- Conditions
- Cardiometabolic Risk Factors, Skin Condition, Cognitive Ability, General, Sleep Quality, Gut-Microbiota
- Keywords
- Endothelial progenitor cells, Gut microbiota, Cardiovascular diseases risk factors, MoCA, Advanced glycation end products, Metabolomics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2025 (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.
This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults.
Detailed description
Diet plays a crucial role in maintaining overall health, and changes in dietary patterns are increasingly recognized as major contributors to chronic disease development. Inadequate dietary intake and poor diet quality have been linked to increased risks of cardiometabolic diseases and disruptions in gut microbiota composition. However, most studies investigating these associations have been conducted on Western populations, and there is a lack of research focusing on Asian populations. Given the genetic, metabolic, and dietary differences between Western and Asian populations, examining these associations in an Asian population is essential for a deeper understanding of population-specific risk factors and health outcomes. Therefore, there is an urgent need to assess the associations between dietary intake, cardiometabolic health, and gut microbiota composition in Asian population.
This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults.
Findings from this study will offer valuable insights into the relationship between diet, cardiometabolic health, and the gut microbiota in this population. In addition, this research may identify specific dietary patterns or nutrients that offer greater benefit for cardiometabolic and gut health. In turn, these findings can contribute to the improvement of current dietary guidelines aimed at promoting better cardiometabolic and gut microbiota outcomes for the broader Singaporean population.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger population | – | –Age 21-64 |
| Middle-aged and older population | – | –Age 65-80 |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Singapore adults
Key inclusion criteria (6 listed)
- Able to give informed consent
- Adults 21-80 years old
- English-literate
- Have venous access sufficient to allow for blood sampling as per the protocol
- No drastic change of diet for the past 1 year
Key exclusion criteria (3 listed)
- Taking dietary supplements and fermented foods, which may impact the gut microbiota (e.g. antibiotics, prebiotics, probiotics, yogurt, kimchi) 2 months before starting the 1st study visit only.
- Taking dietary supplements or medications, which may impact sleep outcomes (e.g. Nutritional Shakes (e.g. Ensure), tryptophan, 5-hydroxytryptophan or melatonin supplementations) 1 month before starting the study.
- Taking dietary supplements which may impact the eye outcomes (e.g. Vitamin A, vitamin A-containing multivitamin) 2 months before starting the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dietary intake
Time frame: Day 7
Use a 3-day food record to document dietary intake
Blood pressure
Time frame: Day 1
Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Blood lipid lipoprotein profile
Time frame: Day 1
Total cholesterol, LDL, HDL, and triglyceride concentration in the blood will be measured
Fasting blood glucose
Time frame: Day 1
Glucose concentration in the blood will be measured
Endothelial Progenitor Cell Count
Time frame: Day 1
Endothelial functions are determined by the percentage of endothelial progenitor cells (CD34+/KDR+) expression in peripheral blood mononuclear cells
Fecal short chain fatty acid (SCFA) concentration
Time frame: Day 1
SCFA concentration in the blood will be measured
Trimethylamine N-oxide (TMAO)
Time frame: Day 1
Trimethylamine N-oxide (TMAO) concentration in the blood will be measured
Fecal bile acids
Time frame: Day 1
Bile acids concentration will be determined from fecal samples of the subjects
Fecal zonulin
Time frame: Day 1
Zonulin concentration will be determined from fecal samples of the subjects
Fecal calprotectin
Time frame: Day 1
Calprotectin concentration will be determined from fecal samples of the subjects
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Day 1
The estimated Glomerular Filtration Rate (eGFR) of the subjects will be measured from the blood
14 secondary outcomes
Sleep quality-Pittsburgh Sleep Quality Index Questionnaire
Time frame: Day 1
Cognitive function
Time frame: Day 1
Skin carotenoid concentration
Time frame: Day 1
Macular Pigment Optical Density (MPOD)
Time frame: Day 1
The Global Physical Activity Questionnaire (GPAQ)
Time frame: Day 1
The Perceived Stress Scale (PSS-10)
Time frame: Day 1
The Beck Anxiety Inventory (BAI)
Time frame: Day 1
The Beck Depression Inventory-II (BDI-II)
Time frame: Day 1
Visual acuity
Time frame: Day 1
Visual function questionnaire 25
Time frame: Day 1
Skin advanced glycation end products (AGE) levels
Time frame: Day 1
Blood advanced glycation end products (AGE) levels
Time frame: Day 1
Contrast sensitivity
Time frame: Day 1
Changes in metabolites found in plasma (plasma metabolomics)
Time frame: Day 1
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 5 Aug 2026.
- Individual participant dataSharing planned: No
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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 principal investigator
Department of Food Science and Technology, 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?
An observational study of Cardiometabolic Risk Factors and Skin Condition, 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 6 inclusion and 3 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 5 Aug 2026. 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?
Dietary intake (time frame: Day 7). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.