Actively Recruiting
Asian-Mediterranean Diet and Women's Health: A Randomized Controlled Trial (A+ MEAL Study)
Led by Global Centre for Asian Women's Health · Updated on 2025-03-12
300
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
G
Global Centre for Asian Women's Health
Lead Sponsor
Y
Yong Loo Lin School of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a healthy, Mediterranean-inspired localized diet called the Asian-Mediterranean diet on the health of Asian women, specifically focusing on cardiometabolic health and potential influences on gut and brain health. This study targets Chinese women in Singapore aged 21 to 50 years who have overweight or obesity, aiming to provide insights that may benefit these women and their families. The study is a randomized controlled trial designed to fill the current gap in evidence about the Mediterranean diet's impact on Asian populations. The trial involves two groups: an intervention group receiving pre-cooked Asian-Mediterranean meals twice daily and pre-packed nuts daily, along with regular dietary consultations, and a control group receiving dietary advice based on national guidelines through a leaflet. The intervention period includes free meals and nuts provided five days a week, with dietary sessions at the start and every four weeks. Participants are randomly assigned to either group in equal numbers. Participants will be involved in the study for up to 20 weeks, with measurements taken at the start, week 12, and up to week 20. These assessments include blood tests for cholesterol types, triglycerides, and inflammation markers such as IL-6 and CRP. The study also tracks adherence to the diet and monitors safety throughout. The trial aims to understand how the diet affects key health indicators over time in this specific group of women.
CONDITIONS
Brief Title
Asian-Mediterranean Diet and Women's Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 21 to 50 years
- Chinese ethnicity
- Singapore citizen, permanent resident, or long-term pass holder
- Able to complete questionnaires in English
- Body mass index (BMI) of 23.0 kg/m2 or higher but less than 37.5 kg/m2
- Not planning to conceive within 12 months from enrollment
- Not planning to leave Singapore for more than 2 consecutive calendar weeks in the next six months
- Not currently pregnant or breastfeeding
- Not currently smoking
- No history of major chronic diseases, major infectious diseases, severe gastrointestinal disorders, or related major medical procedures/surgeries
- No major mental health condition
- No known food allergies, especially to nuts and seafood
- Not on special diets or dietary restrictions such as vegetarian, vegan, ketogenic, or Kosher
- Not currently or planning to enroll in another interventional study affecting weight, cardiometabolic, gut, or brain health in the next six months
You will not qualify if you...
- Does not meet all inclusion criteria
- For MRI procedure, shoulder width 60 cm or more
- Has medical implants or foreign bodies related to heart, brain, or eye (e.g., pacemakers, artificial heart valves, brain stimulation devices, intrauterine devices)
- History of head injury or trauma with loss of consciousness
- Metallic dental braces or dental implants
- Claustrophobia
- Drinks more than 30 units of alcohol per week (where 1 unit = 25mL 40% spirit, 1 can of beer = 2 units, 1 standard glass of wine = 2 units)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants assigned to the intervention arm receive pre-cooked Asian-Mediterranean meals twice a day and pre-packed nuts daily, five days a week, along with dietary consultation sessions at baseline and every four weeks. Participants in the control arm receive dietary advice based on national guidelines at baseline.
Baseline visit and follow-up visits every 4 weeks during treatment
Duration - Up to 8 weeks after treatment
Participants have assessments up to week 20 to monitor outcomes after the treatment period.
Visits at week 12 and up to week 20
Trial Site Locations
Total: 1 location
1
Global Centre for Asian Women's Health
Singapore, Singapore, Singapore, 117549
Actively Recruiting
Research Team
J
Jiaxi Yang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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