Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06825936

Asian-Mediterranean Diet and Women's Health

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Global Centre for Asian Women's Health

Singapore, 117549

Location status: Recruiting

Location contact

Cuilin Zhang, MD, MPH, PhD

PRINCIPAL_INVESTIGATOR

Jiaxi Yang, PhD

CONTACT

[email protected]

+65-8161-3250

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must meet all of the inclusion criteria for participation:

  • Females aged 21-50 years
  • Chinese ethnicity
  • Singapore citizens, permanent residents, or long-term pass holders
  • Is able to complete questionnaires in English
  • BMI ≥ 23.0 kg/m2 but < 37.5 kg/m2
  • Not planning to conceive in the next 12 months from enrolment (you will be asked to withdraw once you conceive during the study period)
  • Not planning to leave Singapore for more than 2 consecutive calendar weeks (10 working days) in the next six months from enrolment
  • Not currently pregnant or breastfeeding
  • Not currently smoking
  • 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
  • Without major mental health condition
  • Without known food allergies, especially to nuts and seafood.
  • Not on any special diets or having dietary restrictions (e.g. vegetarians, vegans, ketogenic, Kosher diet)
  • 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)

Treatment and study plan

Diet intervention

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

Other

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

Primary outcomes

  1. High-density lipoprotein cholesterol (HDL-C)

    Time frame: week 0, week 12, and up to week 20

    High-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw)

  2. Low-density lipoprotein cholesterol (LDL-C)

    Time frame: week 0, week 12, and up to week 20

    Low-density lipoprotein cholesterol (LDL-C) in mg/dL (blood draw)

  3. Low-density lipoprotein cholesterol (LDL-C) to high-density lipoprotein cholesterol (HDL-C) ratio

    Time frame: week 0, week 12, and up to week 20

    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

  4. Triglycerides

    Time frame: week 0, week 12, and up to week 20

    Triglycerides in mg/dL (blood draw)

  5. Interleukin-6 (IL-6)

    Time frame: week 0, week 12, and up to week 20

    Interleukin-6 (IL-6) in pg/mL (blood draw)

  6. C-reactive protein (CRP)

    Time frame: week 0, week 12, and up to week 20

    C-reactive protein (CRP) in mg/L (blood draw)

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaxi Yang, PhD

CONTACT

[email protected]

+65-8161-3250

Sponsors and collaborators

Lead sponsor

Global Centre for Asian Women's Health

Other

Collaborators

  • Yong Loo Lin School of Medicine

Registry information

Official study title

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

Acronym: A+ MEAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.