Asian-Mediterranean Diet and Women's Health: a Randomized Controlled Trial (A+ MEAL Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- High-density lipoprotein cholesterol (HDL-C)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Intervention
Diet intervention consisting of study meals and nuts along with diet advice
干预措施: Diet intervention (Other)
Control
Diet advice following national guidelines
干预措施: Control (Other)
结局指标
主要结局
High-density lipoprotein cholesterol (HDL-C)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: week 0, week 12, and up to week 20
Triglycerides in mg/dL (blood draw)
Interleukin-6 (IL-6)
时间窗: week 0, week 12, and up to week 20
Interleukin-6 (IL-6) in pg/mL (blood draw)
C-reactive protein (CRP)
时间窗: week 0, week 12, and up to week 20
C-reactive protein (CRP) in mg/L (blood draw)
次要结局
未报告次要终点