Asian-Mediterranean Diet and Women's Health (A+ MEAL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Women Health; Cardiometabolic Risk Factors; Cardiometabolic Conditions
• Intervention / Treatment: Other: Diet intervention; Other: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiaxi Yang, PhD; Phone Number: +65-8161-3250; Email: jiaxiyang@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 117549
    • Recruiting
    • Global Centre for Asian Women's Health
    • Contact: Jiaxi Yang, PhD; Phone Number: +65-8161-3250; Email: jiaxiyang@nus.edu.sg
    • Contact: Cuilin Zhang, MD, MPH, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Diet intervention consisting of study meals and nuts along with diet advice	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.
Placebo Comparator: Control; Diet advice following national guidelines	Other: Control; For participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-density lipoprotein cholesterol (HDL-C)	High-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw)	week 0, week 12, and up to week 20
Low-density lipoprotein cholesterol (LDL-C)	Low-density lipoprotein cholesterol (LDL-C) in mg/dL (blood draw)	week 0, week 12, and up to week 20
Low-density lipoprotein cholesterol (LDL-C) to high-density lipoprotein cholesterol (HDL-C) ratio	Low-density lipoprotein cholesterol (LDL-C) in mg/dL and high-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw) to derive LDL-C to HDL-C ratio	week 0, week 12, and up to week 20
Triglycerides	Triglycerides in mg/dL (blood draw)	week 0, week 12, and up to week 20
Interleukin-6 (IL-6)	Interleukin-6 (IL-6) in pg/mL (blood draw)	week 0, week 12, and up to week 20
C-reactive protein (CRP)	C-reactive protein (CRP) in mg/L (blood draw)	week 0, week 12, and up to week 20

Collaborators and Investigators

• Sponsor: Global Centre for Asian Women's Health
• Collaborators: Yong Loo Lin School of Medicine
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 10, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Mediterranean diet; Cardiometabolic risk factors; Women health; Cardiometabolic health
• Other Study ID Numbers: 2023-371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will make a decision on IPD sharing as our trial further progresses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No