Exploring the Asian-Mediterranean diet's impact on women's health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a Mediterranean-inspired diet tailored for Asian women on cardiometabolic health. It is a randomized controlled trial involving up to 300 women of Chinese ethnicity in Singapore, aged 21-50 years. Participants will be divided into two groups: one receiving the diet intervention and the other serving as a control. The study aims to provide insights into how this diet can improve health outcomes for women and their families.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Subjects must meet all of the inclusion criteria for participation:

1. Females aged 21-50 years
2. Chinese ethnicity
3. Singapore citizens, permanent residents, or long-term pass holders
4. Is able to complete questionnaires in English
5. BMI ≥ 23.0 kg/m2 but \< 37.5 kg/m2
6. Not planning to conceive in the next 12 months from enrolment (you will be asked to withdraw once you conceive during the study period)
7. Not planning to leave Singapore for more than 2 consecutive calendar weeks (10 working days) in the next six months from enrolment
8. Not currently pregnant or breastfeeding
9. Not currently smoking
10. Without history of major chronic diseases (e.g., cancer, diabetes, cardiovascular diseases, chronic kidney disease), major infectious diseases (e.g. hepatitis B, HIV), severe gastrointestinal disorders (e.g. colitis or inflammation of the bowel, celiac disease, chronic gastritis) and major medical procedures/surgeries related to these conditions
11. Without major mental health condition
12. Without known food allergies, especially to nuts and seafood.
13. Not on any special diets or having dietary restrictions (e.g. vegetarians, vegans, ketogenic, Kosher diet)
14. Not currently and will not be enrolled in another interventional study or studies that may affect weight, cardiometabolic health, gut, or brain health in the next six months from enrolment

Exclusion Criteria:

Subjects not meeting any of the above inclusion criteria will be excluded from participation.

Additional Exclusion Criteria for MRI procedure only:

i. Shoulder width ≥60cm ii. Has any medical implants or foreign bodies, particularly related to heart, brain, or eye implants, including but not limited to pacemakers, artificial heart valves, implantable cardioverter defibrillators, ventricular assist devices, brain stimulation devices, intrauterine devices, and breast biopsies (if any implant or tissue marker has been placed) iii. History of head injury or trauma with loss of consciousness iv. Metallic dental braces or dental implants v. Having claustrophobia vi. Drinks more than 30 units of alcohol per week (1 unit = 25mL 40% spirit, 1 can of beer = 2 units, 1 standard glass of wine = 2 units)

Where it's running

• Global Centre for Asian Women's Health
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Cuilin Zhang, MD, MPH, PhD — Global Centre for Asian Women's Health, Yong Loo Lin School of Medicine, National University of Singapore
• Study coordinator: Jiaxi Yang, PhD
• Email: jiaxiyang@nus.edu.sg
• Phone: +65-8161-3250

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.