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| Name | Class |
|---|---|
| Yong Loo Lin School of Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Diet intervention consisting of study meals and nuts along with diet advice |
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| Control | Placebo Comparator | Diet advice following national guidelines |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| High-density lipoprotein cholesterol (HDL-C) | High-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw) | week 0, week 12, and up to week 20 |
| Low-density lipoprotein cholesterol (LDL-C) | Low-density lipoprotein cholesterol (LDL-C) in mg/dL (blood draw) | week 0, week 12, and up to week 20 |
| Low-density lipoprotein cholesterol (LDL-C) to high-density lipoprotein cholesterol (HDL-C) ratio | 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 | week 0, week 12, and up to week 20 |
| Triglycerides | Triglycerides in mg/dL (blood draw) | week 0, week 12, and up to week 20 |
| Interleukin-6 (IL-6) | Interleukin-6 (IL-6) in pg/mL (blood draw) | week 0, week 12, and up to week 20 |
| C-reactive protein (CRP) | C-reactive protein (CRP) in mg/L (blood draw) | week 0, week 12, and up to week 20 |
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Inclusion Criteria:
Subjects must meet all of the inclusion criteria for participation:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiaxi Yang, PhD | Contact | +65-8161-3250 | jiaxiyang@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Cuilin Zhang, MD, MPH, PhD | Global Centre for Asian Women's Health, Yong Loo Lin School of Medicine, National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Centre for Asian Women's Health | Recruiting | Singapore | Singapore | 117549 | Singapore |
We will make a decision on IPD sharing as our trial further progresses.
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| Control | Other | For participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline. |
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