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Brown Fat Activation and Browning Efficiency Augmented by Chronic Cold and Nutraceuticals for Brown Adipose Tissue-mediated Effect Against Metabolic Syndrome (BEACON BEAMS Study)

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ClinicalTrials.gov Identifier: NCT04595006
Recruitment Status : Recruiting
First Posted : October 20, 2020
Last Update Posted : May 10, 2022
Sponsor:
Collaborators:
Duke-NUS Graduate Medical School
Canadian Imaging Research Centre (CIRC)
National University, Singapore
Singapore Institute of Food and Biotechnology Innovation (SIFBI)
Singapore Bioimaging Consortium (SBIC)
Information provided by (Responsible Party):
Melvin Leow, Singapore Institute for Clinical Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Energy Expenditure Obesity Brown Adipose Tissue Other: Cold Stimulation (CS) Other: Browning Nutraceutical (BN) Other: Cold Stimulation and Browning Nutraceutical (CSBN) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cold Stimulation (CS)
Subjects will undergo a mild cold stimulation of about 14 degrees Celsius by wearing a cooling vest for approximately an hour daily for the next 12 weeks or 3 months.
Other: Cold Stimulation (CS)
Subject wear cooling vest to stay cool

Experimental: Browning Nutraceutical (BN)
Subjects will consume 2000mg of curcumin daily for the next 12 weeks or 3 months.
Other: Browning Nutraceutical (BN)
Subject will consume 2000mg of curcumin a naturally-occurring polyphenol antioxidant that is found in turmeric ginger rhizome root

Experimental: Cold Stimulation and Browning Nutraceutical (CSBN)
Subjects will undergo a mild cold stimulation of about 14 degrees Celsius by wearing a cooling vest for approximately an hour and consume 2000mg of curcumin daily for the next 12 weeks or 3 months.
Other: Cold Stimulation and Browning Nutraceutical (CSBN)
Subject wear a cooling vest and consume 2000mg of curcumin




Primary Outcome Measures :
  1. Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI. [ Time Frame: Week 0, 12 and 24 of cold stimulus ]
  2. Change in Brown adipose tissue activation detection by Imaging using Infrared [ Time Frame: Week 0, 12 and 24 of cold stimulus ]
  3. Change in Energy Expenditure using Whole Body Calorimeter. [ Time Frame: Week 0, 12 and 24 of cold stimulus ]
  4. Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI. [ Time Frame: Week 0, 12 and 24 of consumption of Curcumin ]
  5. Change in Brown adipose tissue activation detection by Imaging using Infrared [ Time Frame: Week 0, 12 and 24 of consumption of Curcumin ]
  6. Change in Energy Expenditure using Whole Body Calorimeter. [ Time Frame: Week 0, 12 and 24 of consumption of Curcumin ]
  7. Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI. [ Time Frame: Week 0, 12 and 24 of cold stimulus and consumption of curcumin ]
  8. Change in Brown adipose tissue activation detection by Imaging using Infrared [ Time Frame: Week 0, 12 and 24 of cold stimulus and consumption of curcumin ]
  9. Change in Energy Expenditure using Whole Body Calorimeter. [ Time Frame: Week 0, 12 and 24 of cold stimulus and consumption of curcumin ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595006


Contacts
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Contact: Melvin Leow, MMBS 64070105 melvin_leow@sics.a-star.edu.sg
Contact: Lijuan Sun, Phd lijuan_sun@sics.a-star.edu.sg

Locations
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Singapore
Singapore Institute of Clinical Sciences Recruiting
Singapore, Singapore, 117609
Contact: Melvin Leow, MBBS    64070105    melvin_leow@sics.a-star.edu.sg   
Contact: Lijuan Sun, Phd       lijuan_sun@sics.a-star.edu.sg   
Sponsors and Collaborators
Singapore Institute for Clinical Sciences
Duke-NUS Graduate Medical School
Canadian Imaging Research Centre (CIRC)
National University, Singapore
Singapore Institute of Food and Biotechnology Innovation (SIFBI)
Singapore Bioimaging Consortium (SBIC)
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Responsible Party: Melvin Leow, Principal Investigator, Singapore Institute for Clinical Sciences
ClinicalTrials.gov Identifier: NCT04595006    
Other Study ID Numbers: 2018/00823
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases