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RECRUITING

NCT06825936

Asian-Mediterranean Diet and Women's Health

Sponsor: Global Centre for Asian Women's Health

View on ClinicalTrials.gov

Summary

Given the escalating high burdens of overeight and obesity, and related commobidies in Asia, Asian women with overweight/obesity is an important group for targeted intervention in promoting health and wellbeing. A study focused on Asian women at reproductive or early post-menopausal age can inform effective strategies for promoting healthy diet and lifetyle and for optimizing health not only among these women but also for their children and partners. The Mediterranean diet has beneficial effects on cardiometabolic and reproductive health. So far, evidence on the Mediterranean diet and its health benefits mostly come from Western populations. Studies evaluating health effects of Mediterranean diet in Asian population are scant. This study aims to investigate the beneficial effects of a healthy, Mediterranean-inspired localized diet (i.e., Asian-Mediterranean diet) on women's health, such as cardiometabolic health with potential mechanisms through modulating gut and brain health.

Official title: Asian-Mediterranean Diet and Women's Health: A Randomized Controlled Trial (A+ MEAL Study)

Key Details

Gender

FEMALE

Age Range

21 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-02-10

Completion Date

2026-10

Last Updated

2025-03-12

Healthy Volunteers

Yes

Conditions

Cardiometabolic Risk Factors Cardiometabolic Conditions Women Health

Interventions

OTHER

Diet intervention

For participants assigned to the intervention arm, the dietary intervention consists of: a) pre-cooked Asian-Mediterranean meals: participants will receive free meals, two meals a day, five days a week, and b) pre-packed nuts, 30g a day, five days a week, during the intervention period. Additionally, participants will receive a dietary consultation session at baseline and every four weeks.

OTHER

Control

For participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline.

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)

Locations (1)

Global Centre for Asian Women's Health

Singapore, Singapore, Singapore