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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Singapore
Singapore Institute of Clinical Sciences
RECRUITING
Singapore
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 50
Treatments
Experimental: Maslinic Acid
MA (an extract from olive fruit). Each participant will be instructed to take 3 tablets (60 mg or equivalent) daily after breakfast for 12 weeks.
Placebo_comparator: Placebo
Each subject will be instructed to take 3 matching placebo tablets (or equivalent) daily after breakfast for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Institute for Human Development and Potential (IHDP), Singapore
Collaborators: National Medical Research Council (NMRC), Singapore

This content was sourced from clinicaltrials.gov