Active — Not RecruitingNot Applicable

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

Singapore50 participantsStarted 2024-08-15

Plain-language 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.

Who can participate

Age range21 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. 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

What they're measuring

Concentration of blood glucose

Timeframe: Week 0, 12

Rate of brown adipose tissue activation detection using Infrared camera

Timeframe: Week 0, 12

Change in Energy Expenditure using Whole Body Calorimeter

Timeframe: Week 0, 12

Change in Body Mass Index (BMI)

Timeframe: Week 0, 12

Change in Fat percentage

Timeframe: Week 0, 12

Concentration of Insulin level

Timeframe: Week 0, 12

Trial details

NCT IDNCT06484543

SponsorInstitute for Human Development and Potential (IHDP), Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31

View on ClinicalTrials.gov More Diabetes trials

Plain-language summary

Who can participate

Age range21 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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
✓. 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

What they're measuring

Concentration of blood glucose

Timeframe: Week 0, 12

Rate of brown adipose tissue activation detection using Infrared camera

Timeframe: Week 0, 12

Change in Energy Expenditure using Whole Body Calorimeter

Timeframe: Week 0, 12

Change in Body Mass Index (BMI)

Timeframe: Week 0, 12

Change in Fat percentage

Timeframe: Week 0, 12

Concentration of Insulin level

Timeframe: Week 0, 12