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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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

Other trials in Singapore

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.

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 groups in NCT06775132
Study groupRoleWhat they receive
Younger populationAge 21-64
Middle-aged and older populationAge 65-80

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dietary intake

    Use a 3-day food record to document dietary intake

    Measured: Day 7

  2. Blood pressure

    Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.

    Measured: Day 1

  3. Blood lipid lipoprotein profile

    Total cholesterol, LDL, HDL, and triglyceride concentration in the blood will be measured

    Measured: Day 1

  4. Fasting blood glucose

    Glucose concentration in the blood will be measured

    Measured: Day 1

  5. 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

  6. Fecal short chain fatty acid (SCFA) concentration

    SCFA concentration in the blood will be measured

    Measured: Day 1

  7. Trimethylamine N-oxide (TMAO)

    Trimethylamine N-oxide (TMAO) concentration in the blood will be measured

    Measured: Day 1

  8. Fecal bile acids

    Bile acids concentration will be determined from fecal samples of the subjects

    Measured: Day 1

  9. Fecal zonulin

    Zonulin concentration will be determined from fecal samples of the subjects

    Measured: Day 1

  10. Fecal calprotectin

    Calprotectin concentration will be determined from fecal samples of the subjects

    Measured: Day 1

  11. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted14 Jan 2025
  2. Study start3 Feb 2025
  3. Primary completion30 Jun 2026
  4. Study completion31 Dec 2026 (estimated)

Resources

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)
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

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.

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