NCT06825936

Asian-Mediterranean Diet and Women's Health

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Global Centre for Asian Women's Health · Academic / Other
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-10
• Primary completion: 2026-07-01
• Completion: 2026-10-01
• First posted: 2025-02-13
• Last updated: 2025-03-12

Locations

1 site across 1 country: Singapore