Cardiometabolic Conditions, Cardiometabolic Risk Factors, Women Health
Conditions
Keywords
Cardiometabolic health, Mediterranean diet, Women health, Cardiometabolic risk factors
Brief 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.
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
OTHERDiet 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.
OTHERControl
For participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline.
Sponsors
Yong Loo Lin School of Medicine
Global Centre for Asian Women's Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet all of the inclusion criteria for participation: 1. Females aged 21-50 years 2. Chinese ethnicity 3. Singapore citizens, permanent residents, or long-term pass holders 4. Is able to complete questionnaires in English 5. BMI ≥ 23.0 kg/m2 but \< 37.5 kg/m2 6. Not planning to conceive in the next 12 months from enrolment (you will be asked to withdraw once you conceive during the study period) 7. Not planning to leave Singapore for more than 2 consecutive calendar weeks (10 working days) in the next six months from enrolment 8. Not currently pregnant or breastfeeding 9. Not currently smoking 10. 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 11. Without major mental health condition 12. Without known food allergies, especially to nuts and seafood. 13. Not on any special diets or having dietary restrictions (e.g. vegetarians, vegans, ketogenic, Kosher diet) 14. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High-density lipoprotein cholesterol (HDL-C) | week 0, week 12, and up to week 20 | High-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw) |
| Low-density lipoprotein cholesterol (LDL-C) | week 0, week 12, and up to week 20 | Low-density lipoprotein cholesterol (LDL-C) in mg/dL (blood draw) |
| Low-density lipoprotein cholesterol (LDL-C) to high-density lipoprotein cholesterol (HDL-C) ratio | 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 |
| Triglycerides | week 0, week 12, and up to week 20 | Triglycerides in mg/dL (blood draw) |
| Interleukin-6 (IL-6) | week 0, week 12, and up to week 20 | Interleukin-6 (IL-6) in pg/mL (blood draw) |
| C-reactive protein (CRP) | week 0, week 12, and up to week 20 | C-reactive protein (CRP) in mg/L (blood draw) |
Countries
Singapore
Contacts
Primary ContactJiaxi Yang, PhD
Outcome results
None listed