Clinical trial NCT06775132: Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes
Official title: Associations Between Dietary Intake and Cardiometabolic and Gut Microbiota Outcomes in Singapore Adults
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 240
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Singapore adults

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dietary intake
timeFrame: Day 7
measure: Blood pressure
timeFrame: Day 1
measure: Blood lipid lipoprotein profile
timeFrame: Day 1
measure: Fasting blood glucose
timeFrame: Day 1
measure: Endothelial Progenitor Cell Count
timeFrame: Day 1
measure: Fecal short chain fatty acid (SCFA) concentration
timeFrame: Day 1
measure: Trimethylamine N-oxide (TMAO)
timeFrame: Day 1
measure: Fecal bile acids
timeFrame: Day 1
measure: Fecal zonulin
timeFrame: Day 1
measure: Fecal calprotectin
timeFrame: Day 1
measure: Estimated Glomerular Filtration Rate (eGFR)
timeFrame: Day 1
Secondary outcomes:
measure: Sleep quality-Pittsburgh Sleep Quality Index Questionnaire
timeFrame: Day 1
measure: Cognitive function
timeFrame: Day 1
measure: Skin carotenoid concentration
timeFrame: Day 1
measure: Macular Pigment Optical Density (MPOD)
timeFrame: Day 1
measure: The Global Physical Activity Questionnaire (GPAQ)
timeFrame: Day 1
measure: The Perceived Stress Scale (PSS-10)
timeFrame: Day 1
measure: The Beck Anxiety Inventory (BAI)
timeFrame: Day 1
measure: The Beck Depression Inventory-II (BDI-II)
timeFrame: Day 1
measure: Visual acuity
timeFrame: Day 1
measure: Visual function questionnaire 25
timeFrame: Day 1
measure: Skin advanced glycation end products (AGE) levels
timeFrame: Day 1
Other outcomes:
measure: Anthopometric measurements
timeFrame: Day 1
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
affiliation: Department of Food Science and Technology, National University of Singapore
name: Jung Eun Kim
role: PRINCIPAL_INVESTIGATOR
References: