Status:
RECRUITING
Brown Fat as Therapeutic Strategy for Obesity and Associated Metabolic Diseases Via Functional Food/Nutraceutical Approach - Molecular Mechanisms of Pentacyclic Triterpenes (BRACE)
Lead Sponsor:
Institute for Human Development and Potential (IHDP), Singapore
Collaborating Sponsors:
National Medical Research Council (NMRC), Singapore
Conditions:
Diabetes
Brown Adipose Tissue
Eligibility:
All Genders
21-60 years
Phase:
NA
Brief Summary
To examine MA (Maslinic Acid) safety and efficacy in ameliorating insulin resistance and the cardinal features of metabolic syndrome. Chronic exposure to MA as a potent PPARgamma binder nutraceutical ...
Detailed Description
Up to 50 participants that are overweight/obese people suffering from metabolic syndrome/pre-metabolic syndrome will be recruited for this study. They will be asked to come to the Clinical Nutrition R...
Eligibility Criteria
Inclusion
- Male or Female
- Chinese ethnicity
- Age between 21 to 60 years• Able to give informed consent
- Body mass index (BMI) between 23 to 32 kg/m2
- Thyroid function test must be within the normal ranges
- Willing to avail yourself for the whole study and follow study procedures
- EITHER deemed to have pre-metabolic syndrome when waist circumference is \> 90 cm in men or \> 80 cm in women, with none or up to one of the following condition:
- Triglyceride level \>/= 1.7 mmol/L
- HDL cholesterol \</= 1.0 mmol/L in men, and \</= 1.3 mmol/L in women
- Blood pressure \>/= 130/85 mmHg
- Fasting blood glucose \>/= 6.1 mmol/L
- OR deemed to have metabolic syndrome when three or more of the following conditions are present:
- Waist circumference \> 90 cm in men and \> 80 cm in women
- Triglyceride level \>/= 1.7 mmol/L
- HDL cholesterol\</= 1.0 mmol/L in men, and \</= 1.3 mmol/L in women
- Blood pressure \>/= 130/85 mmHg
- Fasting blood glucose \>/= 6.1 mmol/L
Exclusion
- Are pregnant or contemplating pregnancy (for female subjects)
- Partake in sports at the competitive and/ or endurance levels
- Have known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Have major chronic disease such as heart disease or cancer
- Take insulin or drugs known to affect glucose metabolism
- Intentionally restrict food intake
- Have major medical or surgical event requiring hospitalization within the preceding 3 months
- Have taken antibiotics for 3 months before the study period
- Are a smoker
- Are an overnight shift worker
- Have any known food allergy (eg. anaphylaxis to peanuts) or skin allergy (eg. rashes due to alcohol, etc)
- Having active Tuberculosis (TB) or currently receiving treatment for TB
- Have any known Chronic Infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)
- Are a member of the research team or their immediate family members. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
- Enrolled in a concurrent research study judged not to be scientifically or medically compatible with this study
- Have poor veins impeding venous access
- Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws
- History of claustrophobia
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06484543
Start Date
August 15 2024
End Date
August 31 2027
Last Update
October 15 2024
Active Locations (1)
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1
Singapore Institute of Clinical Sciences
Singapore, Singapore