Cardiometabolic Risk FactorsA+ MEALNCT06825936
Asian-Mediterranean Diet and Women's Health
A study testing Diet intervention in people with Cardiometabolic Risk Factors and Cardiometabolic Conditions, run by Global Centre for Asian Women's Health at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors, Cardiometabolic Conditions, Women Health
- What is being tested?
- Diet intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Feb 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- Subjects not meeting any of the above inclusion criteria will be excluded from participation.
- Additional Exclusion Criteria for MRI procedure only:
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Global Centre for Asian Women's Health
Singapore, Singapore, 117549
Jiaxi Yang, PhD, +65-8161-3250, jiaxiyang@nus.edu.sg
Cuilin Zhang, MD, MPH, PhD
About this study
Official title: Asian-Mediterranean Diet and Women's Health: A Randomized Controlled Trial (A+ MEAL Study)
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.
Read the 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.
- Being tested
- Diet intervention, Control
- Keywords
- Cardiometabolic health, Mediterranean diet, Women health, Cardiometabolic risk factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet interventionOther
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.
ControlOther
For participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Diet intervention consisting of study meals and nuts along with diet advice Receives: Other: Diet intervention |
| Control | Placebo comparator | Diet advice following national guidelines Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-density lipoprotein cholesterol (HDL-C)
High-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw)
Measured: 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)
Measured: 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
Measured: week 0, week 12, and up to week 20
Triglycerides
Triglycerides in mg/dL (blood draw)
Measured: week 0, week 12, and up to week 20
Interleukin-6 (IL-6)
Interleukin-6 (IL-6) in pg/mL (blood draw)
Measured: week 0, week 12, and up to week 20
C-reactive protein (CRP)
C-reactive protein (CRP) in mg/L (blood draw)
Measured: week 0, week 12, and up to week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start10 Feb 2025
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Global Centre for Asian Women's Health
- Sponsor type
- University, hospital or other
- Collaborators
- Yong Loo Lin School of Medicine
- Responsible party
- Sponsor
- Investigators
- Cuilin Zhang, MD, MPH, PhD, Principal investigator, Global Centre for Asian Women's Health, Yong Loo Lin School of Medicine, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825936
- Sponsor's protocol ID
- 2023-371
- Acronym
- A+ MEAL
- Status last verified
- Mar 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will make a decision on IPD sharing as our trial further progresses.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian-Mediterranean Diet and Women's Health: A Randomized Controlled Trial (A+ MEAL Study)
- ClinicalTrials.gov ID
- NCT06825936
- Acronym / sponsor ID
- A+ MEAL / 2023-371
- Keywords
- Cardiometabolic health, Mediterranean diet, Women health, Cardiometabolic risk factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Global Centre for Asian Women's HealthUniversity, hospital or other
- Collaborators
- Yong Loo Lin School of Medicine
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Diet interventionDiet intervention consisting of study meals and nuts along with diet advice |
| Control | Placebo comparator | Other: ControlDiet advice following national guidelines |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (3 listed)
- Subjects not meeting any of the above inclusion criteria will be excluded from participation.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet 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. | Other | Intervention |
| ControlFor participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline. | Other | Control |
Primary outcome
High-density lipoprotein cholesterol (HDL-C)
Time frame: 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)
Time frame: 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
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
Triglycerides
Time frame: week 0, week 12, and up to week 20
Triglycerides in mg/dL (blood draw)
Interleukin-6 (IL-6)
Time frame: week 0, week 12, and up to week 20
Interleukin-6 (IL-6) in pg/mL (blood draw)
C-reactive protein (CRP)
Time frame: week 0, week 12, and up to week 20
C-reactive protein (CRP) in mg/L (blood draw)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided. We will make a decision on IPD sharing as our trial further progresses.
Related trials for Cardiometabolic Risk Factors
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
Active, not recruiting
Trial of Pistachio Consumption in Older Adults
Cognition, Cardiometabolic Risk Factors
Active, not recruiting
Effect of a Ginger-Based Beverage on Inflammation, Oxidative Stress, and Endothelial Function
Inflammation Biomarkers, Oxidative Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cuilin Zhang, MD, MPH, PhD principal investigator
Global Centre for Asian Women's Health, Yong Loo Lin School of Medicine, National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention in people with Cardiometabolic Risk Factors and Cardiometabolic Conditions, run by Global Centre for Asian Women's Health at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaxi Yang, PhD (+65-8161-3250, jiaxiyang@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-density lipoprotein cholesterol (HDL-C) (time frame: week 0, week 12, and up to week 20). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.