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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 50
Healthy Volunteers: t
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‣ 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

Locations
Other Locations
Singapore
Global Centre for Asian Women's Health
RECRUITING
Singapore
Contact Information
Primary
Jiaxi Yang, PhD
jiaxiyang@nus.edu.sg
+65-8161-3250
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2026-10
Participants
Target number of participants: 300
Treatments
Active_comparator: Intervention
Diet intervention consisting of study meals and nuts along with diet advice
Placebo_comparator: Control
Diet advice following national guidelines
Related Therapeutic Areas
Sponsors
Collaborators: Yong Loo Lin School of Medicine
Leads: Global Centre for Asian Women's Health

This content was sourced from clinicaltrials.gov

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