Asian-Mediterranean Diet and Women's Health

NCT06825936 | Recruiting DMC

• 1 other identifier: 2023-371
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiometabolic Risk Factors; Cardiometabolic Conditions; Women Health

Keywords

Cardiometabolic health; Mediterranean diet; Women health; Cardiometabolic risk factors

Outcome Measures

Primary Outcomes (6)

• High-density lipoprotein cholesterol (HDL-C)

  High-density lipoprotein cholesterol (HDL-C) in mg/dL (blood draw)

  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)

  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

  week 0, week 12, and up to week 20

• Triglycerides

  Triglycerides in mg/dL (blood draw)

  week 0, week 12, and up to week 20

• Interleukin-6 (IL-6)

  Interleukin-6 (IL-6) in pg/mL (blood draw)

  week 0, week 12, and up to week 20

• C-reactive protein (CRP)

  C-reactive protein (CRP) in mg/L (blood draw)

  week 0, week 12, and up to week 20

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Diet intervention consisting of study meals and nuts along with diet advice

Other: Diet intervention

Control

PLACEBO COMPARATOR

Diet advice following national guidelines

Other: Control

Interventions

Diet intervention OTHER

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.

Intervention

Control OTHER

For participants assigned to the control arm, they will receive a leaflet with dietary advice based on national guidelines at baseline.

Control

Eligibility Criteria

• Age: 21 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Global Centre for Asian Women's Health: lead
• Yong Loo Lin School of Medicine: collaborator

Study Sites (1)

Global Centre for Asian Women's Health

Singapore, Singapore, 117549, Singapore

RECRUITING

Study Officials

• Cuilin Zhang, MD, MPH, PhD

  Global Centre for Asian Women's Health, Yong Loo Lin School of Medicine, National University of Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaxi Yang, PhD

CONTACT

+65-8161-3250; jiaxiyang@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 13, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

SG (1)