NCT04595006

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
27mo left

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jan 2021Aug 2028

First Submitted

Initial submission to the registry

October 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2028

Expected
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2.8 years

First QC Date

October 14, 2020

Last Update Submit

May 1, 2025

Conditions

Energy ExpenditureObesityBrown Adipose Tissue

Outcome Measures

Primary Outcomes (9)

  • Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI.

    Week 0, 12 and 24 of cold stimulus

  • Change in Brown adipose tissue activation detection by Imaging using Infrared

    Week 0, 12 and 24 of cold stimulus

  • Change in Energy Expenditure using Whole Body Calorimeter.

    Week 0, 12 and 24 of cold stimulus

  • Change in Brown adipose tissue activation detection by Imaging using 18-FDG-PET/ MRI.

    Week 0, 12 and 24 of consumption of Curcumin

  • Change in Brown adipose tissue activation detection by Imaging using Infrared

    Week 0, 12 and 24 of consumption of Curcumin

  • Change in Energy Expenditure using Whole Body Calorimeter.

    Week 0, 12 and 24 of consumption of Curcumin

  • 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

  • Change in Brown adipose tissue activation detection by Imaging using Infrared

    Week 0, 12 and 24 of cold stimulus and consumption of curcumin

  • Change in Energy Expenditure using Whole Body Calorimeter.

    Week 0, 12 and 24 of cold stimulus and consumption of curcumin

Study Arms (3)

Cold Stimulation (CS)

EXPERIMENTAL

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)

Browning Nutraceutical (BN)

EXPERIMENTAL

Subjects will consume 2000mg of curcumin daily for the next 12 weeks or 3 months.

Other: Browning Nutraceutical (BN)

Cold Stimulation and Browning Nutraceutical (CSBN)

EXPERIMENTAL

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)

Interventions

Cold Stimulation (CS)OTHER

Subject wear cooling vest to stay cool

Cold Stimulation (CS)
Browning Nutraceutical (BN)OTHER

Subject will consume 2000mg of curcumin a naturally-occurring polyphenol antioxidant that is found in turmeric ginger rhizome root

Browning Nutraceutical (BN)
Cold Stimulation and Browning Nutraceutical (CSBN)OTHER

Subject wear a cooling vest and consume 2000mg of curcumin

Cold Stimulation and Browning Nutraceutical (CSBN)

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +3 more criteria

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)
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Institute of Clinical Sciences

Singapore, 117609, Singapore

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

January 15, 2021

Primary Completion

October 31, 2023

Study Completion (Estimated)

August 16, 2028

Last Updated

May 6, 2025

Record last verified: 2025-05

Locations

SG(1)