Brown Fat Activation and Browning Efficiency Augmented by Chronic Cold and Nutraceuticals for Bro… (NCT04595006) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Brown Fat Activation and Browning Efficiency Augmented by Chronic Cold and Nutraceuticals for Brown Adipose Tissue-mediated Effect Against Metabolic Syndrome (BEACON BEAMS Study)
Singapore60 participantsStarted 2021-01-15
Plain-language summary
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.
Who can participate
Age range
21 Years – 50 Years
Sex
ALL
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:
* 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 mont…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI.
Timeframe: Week 0, 12 and 24 of cold stimulus
2
Change in Brown adipose tissue activation detection by Imaging using Infrared
Timeframe: Week 0, 12 and 24 of cold stimulus
3
Change in Energy Expenditure using Whole Body Calorimeter.
Timeframe: Week 0, 12 and 24 of cold stimulus
4
Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI.
Timeframe: Week 0, 12 and 24 of consumption of Curcumin
5
Change in Brown adipose tissue activation detection by Imaging using Infrared
Timeframe: Week 0, 12 and 24 of consumption of Curcumin
6
Change in Energy Expenditure using Whole Body Calorimeter.
Timeframe: Week 0, 12 and 24 of consumption of Curcumin
7
Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI.
Trial details
NCT IDNCT04595006
SponsorInstitute for Human Development and Potential (IHDP), Singapore