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Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes

Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes in Singapore Adults

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06775132
Enrollment
240
Registered
2025-01-14
Start date
2025-02-03
Completion date
2026-12-31
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Risk Factors, Cognitive Ability, General, Gut-Microbiota, Skin Condition, Sleep Quality

Keywords

Endothelial progenitor cells, Gut microbiota, Cardiovascular diseases risk factors, MoCA, Advanced glycation end products, Metabolomics

Brief summary

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.

Interventions

None listed

Sponsors

National University of Singapore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Dietary intakeDay 7Use a 3-day food record to document dietary intake
Blood pressureDay 1Systolic and diastolic blood pressure (in mmHg) will be measured by a blood pressure monitor.
Blood lipid lipoprotein profileDay 1Total cholesterol, LDL, HDL, and triglyceride concentration in the blood will be measured
Fasting blood glucoseDay 1Glucose concentration in the blood will be measured
Endothelial Progenitor Cell CountDay 1Endothelial functions are determined by the percentage of endothelial progenitor cells (CD34+/KDR+) expression in peripheral blood mononuclear cells
Fecal short chain fatty acid (SCFA) concentrationDay 1SCFA concentration in the blood will be measured
Trimethylamine N-oxide (TMAO)Day 1Trimethylamine N-oxide (TMAO) concentration in the blood will be measured
Fecal bile acidsDay 1Bile acids concentration will be determined from fecal samples of the subjects
Fecal zonulinDay 1Zonulin concentration will be determined from fecal samples of the subjects
Fecal calprotectinDay 1Calprotectin concentration will be determined from fecal samples of the subjects
Estimated Glomerular Filtration Rate (eGFR)Day 1The estimated Glomerular Filtration Rate (eGFR) of the subjects will be measured from the blood

Secondary

MeasureTime frameDescription
Sleep quality-Pittsburgh Sleep Quality Index QuestionnaireDay 1Pittsburgh 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.
Cognitive functionDay 1Use 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.
Skin carotenoid concentrationDay 1Skin 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.
Macular Pigment Optical Density (MPOD)Day 1Macular Pigment Optical Density (MPOD): A measurement of macular pigment of the eye using a heterochromatic flicker photometry device. The measurements are in arbitrary units.
The Global Physical Activity Questionnaire (GPAQ)Day 1The 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.
The Perceived Stress Scale (PSS-10)Day 1The 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.
The Beck Anxiety Inventory (BAI)Day 1The 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.
The Beck Depression Inventory-II (BDI-II)Day 1The 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.
Visual acuityDay 1Participants 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.
Visual function questionnaire 25Day 1A 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.
Skin advanced glycation end products (AGE) levelsDay 1Skin 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.
Blood advanced glycation end products (AGE) levelsDay 1The 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.
Contrast sensitivityDay 1Participants 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.
Changes in metabolites found in plasma (plasma metabolomics)Day 1Untargeted metabolomics profiling of plasma will be conducted using ultra performance liquid chromatography-quadrupole time of flight-mass spectrometry (UPLC-QTOF-MS)

Countries

Singapore

Contacts

PRINCIPAL_INVESTIGATORJung Eun Kim

Department of Food Science and Technology, National University of Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026