Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes

May 19, 2025 updated by: Jung Eun Kim, National University of Singapore

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Singapore, Singapore, 117546
        • Recruiting
        • National University of Singapore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Singapore adults

Description

Inclusion Criteria:

  1. Able to give informed consent
  2. Adults 21-80 years old
  3. English-literate
  4. Have venous access sufficient to allow for blood sampling as per the protocol
  5. No drastic change of diet for the past 1 year
  6. If taking medication, has been consistently taking antihypertensive/cholesterol-lowering/type-2 diabetic medication for more than 5 years prior to starting the study.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Taking dietary supplements which may impact the eye outcomes (e.g. Vitamin A, vitamin A-containing multivitamin) 2 months before starting the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Younger population
Age 21-64
Middle-aged and older population
Age 65-80

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary intake
Time Frame: Day 7
Use a 3-day food record to document dietary intake
Day 7
Blood pressure
Time Frame: Day 1
Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Day 1
Blood lipid lipoprotein profile
Time Frame: Day 1
Total cholesterol, LDL, HDL, and triglyceride concentration in the blood will be measured
Day 1
Fasting blood glucose
Time Frame: Day 1
Glucose concentration in the blood will be measured
Day 1
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
Day 1
Fecal short chain fatty acid (SCFA) concentration
Time Frame: Day 1
SCFA concentration in the blood will be measured
Day 1
Trimethylamine N-oxide (TMAO)
Time Frame: Day 1
Trimethylamine N-oxide (TMAO) concentration in the blood will be measured
Day 1
Fecal bile acids
Time Frame: Day 1
Bile acids concentration will be determined from fecal samples of the subjects
Day 1
Fecal zonulin
Time Frame: Day 1
Zonulin concentration will be determined from fecal samples of the subjects
Day 1
Fecal calprotectin
Time Frame: Day 1
Calprotectin concentration will be determined from fecal samples of the subjects
Day 1
Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Day 1
The estimated Glomerular Filtration Rate (eGFR) of the subjects will be measured from the blood
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality-Pittsburgh Sleep Quality Index Questionnaire
Time Frame: Day 1
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.
Day 1
Cognitive function
Time Frame: Day 1
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.
Day 1
Skin carotenoid concentration
Time Frame: Day 1
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.
Day 1
Macular Pigment Optical Density (MPOD)
Time Frame: Day 1
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.
Day 1
The Global Physical Activity Questionnaire (GPAQ)
Time Frame: Day 1
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.
Day 1
The Perceived Stress Scale (PSS-10)
Time Frame: Day 1
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.
Day 1
The Beck Anxiety Inventory (BAI)
Time Frame: Day 1
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.
Day 1
The Beck Depression Inventory-II (BDI-II)
Time Frame: Day 1
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.
Day 1
Visual acuity
Time Frame: Day 1
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.
Day 1
Visual function questionnaire 25
Time Frame: Day 1
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.
Day 1
Skin advanced glycation end products (AGE) levels
Time Frame: Day 1
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.
Day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthopometric measurements
Time Frame: Day 1
Height, weight, and waist circumference will be measured for each subject
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jung Eun Kim, Department of Food Science and Technology, National University of Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

May 21, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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