Asian-Mediterranean Diet and Women's Health

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• High-density lipoprotein cholesterol (HDL-C) [Time frame: week 0, week 12, and up to week 20]
• Low-density lipoprotein cholesterol (LDL-C) [Time frame: week 0, week 12, and up to week 20]
• 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]
• Triglycerides [Time frame: week 0, week 12, and up to week 20]
• Interleukin-6 (IL-6) [Time frame: week 0, week 12, and up to week 20]
• C-reactive protein (CRP) [Time frame: week 0, week 12, and up to week 20]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Other

Study locations

Singapore · 1 center

• Global Centre for Asian Women's Health — Singapore

Identifiers

NCT: NCT06825936 · 2023-371

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗