Asian-Mediterranean Diet and Women's Health

NCT ID: NCT06825936

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2026-10-31

Brief 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.

Detailed Description

This study is a two-arm, single-centre, randomized controlled trial (RCT) involving up to 300 women of Chinese ethnicity in Singapore between 21-50 years old. Upon enrollment, participants will be randomized into one of two study arms (Intervention (up to 150 women), Control (up to 150 women)) in 1:1 ratio.

Conditions

Cardiometabolic Risk Factors; Cardiometabolic Conditions; Women Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention

Diet intervention consisting of study meals and nuts along with diet advice

Group Type: ACTIVE_COMPARATOR

Diet intervention

Intervention Type: OTHER

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.

Control

Diet advice following national guidelines

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Control

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yong Loo Lin School of Medicine

OTHER

Sponsor Role: collaborator

Global Centre for Asian Women's Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cuilin Zhang, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Global Centre for Asian Women's Health, Yong Loo Lin School of Medicine, National University of Singapore

Locations

Global Centre for Asian Women's Health

Singapore, Singapore, Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Jiaxi Yang, PhD

Role: CONTACT

jiaxiyang@nus.edu.sg

+65-8161-3250

Facility Contacts

Jiaxi Yang, PhD

Role: primary

jiaxiyang@nus.edu.sg

+65-8161-3250

Other Identifiers

2023-371

Identifier Type: -

Identifier Source: org_study_id