Using Maslinic Acid to Treat Obesity and Metabolic Issues
Brown Fat as Therapeutic Strategy for Obesity and Associated Metabolic Diseases Via Functional/Nutraceutical Approach - Molecular Mechanisms of Pentacyclic Triterpenes (BRACE)
This study is testing if Maslinic Acid can help improve metabolic health in overweight or obese Chinese individuals over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Institute for Human Development and Potential (IHDP), Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06484543 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of Maslinic Acid, a natural compound, in improving insulin resistance and other features of metabolic syndrome over a 12-week period. Participants will undergo a series of assessments, including body measurements and blood tests, to evaluate changes in metabolic health. The study aims to recruit up to 50 overweight or obese individuals of Chinese ethnicity, who will be randomly assigned to receive either Maslinic Acid or a placebo. The primary focus is on various metabolic parameters, including waist circumference, blood pressure, and blood glucose levels.
Who should consider this trial
Good fit: Ideal candidates are overweight or obese individuals of Chinese ethnicity, aged 21 to 60, with pre-metabolic syndrome or metabolic syndrome.
Not a fit: Patients who are not of Chinese ethnicity or those with a BMI outside the specified range will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel dietary intervention for managing obesity and metabolic syndrome.
How similar studies have performed: While the use of natural compounds for metabolic health is an emerging field, this specific approach with Maslinic Acid has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 1. Triglyceride level \>/= 1.7 mmol/L 2. HDL cholesterol \</= 1.0 mmol/L in men, and \</= 1.3 mmol/L in women 3. Blood pressure \>/= 130/85 mmHg 4. Fasting blood glucose \>/= 6.1 mmol/L * OR deemed to have metabolic syndrome when three or more of the following conditions are present: 1. Waist circumference \> 90 cm in men and \> 80 cm in women 2. Triglyceride level \>/= 1.7 mmol/L 3. HDL cholesterol\</= 1.0 mmol/L in men, and \</= 1.3 mmol/L in women 4. Blood pressure \>/= 130/85 mmHg 5. Fasting blood glucose \>/= 6.1 mmol/L Exclusion Criteria: * 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
Where this trial is running
Singapore
- Singapore Institute of Clinical Sciences — Singapore, Singapore (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.