Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes

NCT06775132 | Recruiting

• 1 other identifier: S27
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional study aims to investigate the associations between dietary intake, cardiometabolic health markers, and gut microbiota composition in Singapore adults.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (11)

• Dietary intake

  Use a 3-day food record to document dietary intake

  Day 7

• Blood pressure

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

  Day 1

• Blood lipid lipoprotein profile

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

  Day 1

• Fasting blood glucose

  Glucose concentration in the blood will be 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

  Day 1

• Fecal short chain fatty acid (SCFA) concentration

  SCFA concentration in the blood will be measured

  Day 1

• Trimethylamine N-oxide (TMAO)

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

  Day 1

• Fecal bile acids

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

  Day 1

• Fecal zonulin

  Zonulin concentration will be determined from fecal samples of the subjects

  Day 1

• Fecal calprotectin

  Calprotectin concentration will be determined from fecal samples of the subjects

  Day 1

• Estimated Glomerular Filtration Rate (eGFR)

  The estimated Glomerular Filtration Rate (eGFR) of the subjects will be measured from the blood

  Day 1

Secondary Outcomes (11)

• Sleep quality-Pittsburgh Sleep Quality Index Questionnaire

  Day 1

• Cognitive function

  Day 1

• Skin carotenoid concentration

  Day 1

• Macular Pigment Optical Density (MPOD)

  Day 1

• The Global Physical Activity Questionnaire (GPAQ)

  Day 1

Other Outcomes (1)

• Anthopometric measurements

  Day 1

Study Arms (2)

Younger population

Age 21-64

Middle-aged and older population

Age 65-80

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Singapore adults

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, Singapore, 117546, Singapore

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, stool

MeSH Terms

Conditions

Skin Diseases; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jung Eun Kim

  Department of Food Science and Technology, National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Yueying

CONTACT

+65 83136733; yueying.yao@u.nus.edu

Jung Eun Kim, PhD, RD

CONTACT

fstkje@nus.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 14, 2025
• Study Start: February 3, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)