Exploring the Asian-Mediterranean diet's impact on women's health
Asian-Mediterranean Diet and Women's Health: A Randomized Controlled Trial (A+ MEAL Study)
NA · Global Centre for Asian Women's Health · NCT06825936
This study is testing whether a Mediterranean-style diet designed for Asian women can improve heart and metabolic health in women aged 21-50 in Singapore.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 21 Years to 50 Years |
| Sex | Female |
| Sponsor | Global Centre for Asian Women's Health (other) |
| Locations | 1 site (Singapore, Singapore) |
| Trial ID | NCT06825936 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are Chinese women aged 21-50 years with a BMI between 23.0 and 37.5 kg/m2 living in Singapore.
Not a fit: Patients who are pregnant, breastfeeding, or have major chronic diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cardiometabolic health and overall well-being for Asian women.
How similar studies have performed: While studies on the Mediterranean diet's benefits exist, this approach focusing on Asian populations is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Singapore, Singapore
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiometabolic Risk Factors, Cardiometabolic Conditions, Women Health, Cardiometabolic health, Mediterranean diet, Women health, Cardiometabolic risk factors