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ACTIVE NOT RECRUITING

NCT06484543

Brown Fat as Therapeutic Strategy for Obesity and Associated Metabolic Diseases Via Functional Food/Nutraceutical Approach - Molecular Mechanisms of Pentacyclic Triterpenes (BRACE)

Sponsor: Institute for Human Development and Potential (IHDP), Singapore

View on ClinicalTrials.gov

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 over 12 weeks will result in improvement in the features of metabolic syndrome including waist circumference, blood pressure, serum HDL-C level, fasting serum triglycerides and fasting plasma glucose. Expected secondary endpoints include favorable changes in metabolic rate, respiratory quotient, fat oxidation, body composition, weight, BAT/WAT compartments, batokines/adipokines, proinflammatory biomarkers, insulin sensitivity and beta cell function.

Official title: Brown Fat as Therapeutic Strategy for Obesity and Associated Metabolic Diseases Via Functional/Nutraceutical Approach - Molecular Mechanisms of Pentacyclic Triterpenes (BRACE)

Key Details

Gender

All

Age Range

21 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-15

Completion Date

2027-08-31

Last Updated

2026-04-09

Healthy Volunteers

Yes

Conditions

Diabetes Brown Adipose Tissue

Interventions

OTHER

Maslinic Acid

Consumption of Maslinic Acid for 12 weeks

OTHER

Placebo

Consumption of Placebo for 12 weeks

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

Locations (1)

Singapore Institute of Clinical Sciences

Singapore, Singapore