Asian-Mediterranean Diet and Women's Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-50
SponsorGlobal Centre for Asian Women's Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Females aged 21-50 years
Chinese ethnicity
Singapore citizens, permanent residents, or long-term pass holders
Is able to complete questionnaires in English
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Diet intervention
Other interventionFor 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.
Control
Other interventionFor participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: InterventionActive comparator 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
High-density lipoprotein cholesterol (HDL-C)
High-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw)
Time frame
week 0, week 12, and up to week 202
Low-density lipoprotein cholesterol (LDL-C)
Low-density lipoprotein cholesterol (LDL-C) in mg/dL (blood draw)
Time frame
week 0, week 12, and up to week 203
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
Time frame
week 0, week 12, and up to week 204
Triglycerides
Triglycerides in mg/dL (blood draw)
Time frame
week 0, week 12, and up to week 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Global Centre for Asian Women's Health
Lead sponsor
Yong Loo Lin School of Medicine
Collaborator
Source ClinicalTrials.gov