Global Centre for Asian Women's Health
Singapore, 117549
Location status: Recruiting
Location contact
Cuilin Zhang, MD, MPH, PhD
PRINCIPAL_INVESTIGATOR
Jiaxi Yang, PhD
CONTACT
NCT Number: NCT06825936
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.
Interested in participating?
Request Info21 year–50 year
Female
Interventional
Not applicable
Singapore, 117549
Location status: Recruiting
Cuilin Zhang, MD, MPH, PhD
PRINCIPAL_INVESTIGATOR
Jiaxi Yang, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
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.
For participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline.
Time frame: week 0, week 12, and up to week 20
High-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw)
Time frame: week 0, week 12, and up to week 20
Low-density lipoprotein cholesterol (LDL-C) in mg/dL (blood draw)
Time frame: 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
Time frame: week 0, week 12, and up to week 20
Triglycerides in mg/dL (blood draw)
Time frame: week 0, week 12, and up to week 20
Interleukin-6 (IL-6) in pg/mL (blood draw)
Time frame: week 0, week 12, and up to week 20
C-reactive protein (CRP) in mg/L (blood draw)
Contact information is provided by the study sponsor or research team.
Global Centre for Asian Women's Health
Other
Asian-Mediterranean Diet and Women's Health: A Randomized Controlled Trial (A+ MEAL Study)
Acronym: A+ MEAL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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