Obesity Clinical Trial
Official title:
Brown Fat Activation and Browning Efficiency Augmented by Chronic Cold and Nutraceuticals for Brown Adipose Tissue-mediated Effect Against Metabolic Syndrome (BEACON BEAMS Study)
Our body fat (adipose tissue) is largely made up of white adipose tissue (WAT) that stores surplus energy as white fat depots. In addition, adult humans have another type of fat similar to the brown fat in babies that burns up fat to generate heat for maintenance of body temperature during cold exposure. Adults have much lesser amounts of such brown adipose tissue (BAT), most of which are located within the sides of the neck and under the skin above the collar bones as well as along the sides of the spine. BAT consists of both classical brown fat identical to that found in babies as well as beige fat (composed of brown-in-white or 'brite' fat cells) found mainly in adults. Both types of BAT burn fat upon activation by various stimuli such as cold or by substances like curcumin found in turmeric ginger rhizome root. This study is carried out to find out the effects of cold stimulation and/or a known BAT-activating nutraceutical among those overweight/obese people suffering from metabolic syndrome.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | November 1, 2024 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 50 Years |
Eligibility | Inclusion Criteria: - Male or Female - Chinese, Malay or Indian ethnicity - Age between 21 to 50 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 of = 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 of = 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) - 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 the study of the CNRC - Have poor veins impeding venous access - Have any history of severe vasovagal syncope (blackouts or near faints) following blood draws - History of surgery with metallic clips, staples or stents - Presence of cardiac pacemaker or other foreign body in any part of the body - History of claustrophobia particularly in a MRI scanner |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore Institute of Clinical Sciences | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore Institute for Clinical Sciences | Canadian Imaging Research Centre (CIRC), Duke-NUS Graduate Medical School, National University of Singapore, Singapore Bioimaging Consortium (SBIC), Singapore Institute of Food and Biotechnology Innovation (SIFBI) |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI. | Week 0, 12 and 24 of cold stimulus | ||
Primary | Change in Brown adipose tissue activation detection by Imaging using Infrared | Week 0, 12 and 24 of cold stimulus | ||
Primary | Change in Energy Expenditure using Whole Body Calorimeter. | Week 0, 12 and 24 of cold stimulus | ||
Primary | Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI. | Week 0, 12 and 24 of consumption of Curcumin | ||
Primary | Change in Brown adipose tissue activation detection by Imaging using Infrared | Week 0, 12 and 24 of consumption of Curcumin | ||
Primary | Change in Energy Expenditure using Whole Body Calorimeter. | Week 0, 12 and 24 of consumption of Curcumin | ||
Primary | Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI. | Week 0, 12 and 24 of cold stimulus and consumption of curcumin | ||
Primary | Change in Brown adipose tissue activation detection by Imaging using Infrared | Week 0, 12 and 24 of cold stimulus and consumption of curcumin | ||
Primary | Change in Energy Expenditure using Whole Body Calorimeter. | Week 0, 12 and 24 of cold stimulus and consumption of curcumin |
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