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

NCT06484543 | Active Not Recruiting

• 1 other identifier: 2024/00022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes; Brown Adipose Tissue

Outcome Measures

Primary Outcomes (6)

• Concentration of blood glucose

  Week 0, 12

• Rate of brown adipose tissue activation detection using Infrared camera

  Week 0, 12

• Change in Energy Expenditure using Whole Body Calorimeter

  Week 0, 12

• Change in Body Mass Index (BMI)

  Measurement of weight and height

  Week 0, 12

• Change in Fat percentage

  Week 0, 12

• Concentration of Insulin level

  Week 0, 12

Study Arms (2)

Maslinic Acid

EXPERIMENTAL

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.

Other: Maslinic Acid

Placebo

PLACEBO COMPARATOR

Each subject will be instructed to take 3 matching placebo tablets (or equivalent) daily after breakfast for 12 weeks.

Other: Placebo

Interventions

Maslinic Acid OTHER

Consumption of Maslinic Acid for 12 weeks

Maslinic Acid

Placebo OTHER

Consumption of Placebo for 12 weeks

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Human Development and Potential (IHDP), Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Singapore Institute of Clinical Sciences

Singapore, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

maslinic acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study in which the participants will not know which group will be assigned to and only the investigators will know.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single blinded study

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: July 3, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)