NCT02790255

Brief Summary

The whole body calorimeter is sensitive enough to reliably measure cold-induced thermogenesis as a surrogate marker of brown adipose tissue (BAT) activation. The infrared (IR) energy flux from activated BAT can be accurately imaged and quantified using an IR imaging device, and that this IR energy output may be correlated to the increased energy expenditure quantified by the whole body calorimeter.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Status
completed

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 Start

First participant enrolled

November 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2018

Completed
Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

4 years

First QC Date

May 31, 2016

Last Update Submit

May 14, 2019

Conditions

Energy ExpenditureObesityAdipose Tissue, Brown

Outcome Measures

Primary Outcomes (1)

  • Temperature at cervical-supraclavicular region

    The temperature at the cervical-supraclavicular region following cold exposure will be determined using infrared thermal imaging.

    45 minutes cold exposure

Secondary Outcomes (1)

  • Energy expenditure during cold exposure

    45 minutes cold exposure

Study Arms (2)

Cold air

EXPERIMENTAL

Subjects to be seated in an airtight chamber at an ambient temperature between 16 to 20 degrees Celsius for 1 hour.

Other: Cold air

Cold water

EXPERIMENTAL

Subjects to be seated in an airtight chamber at an ambient temperature of 24 degrees Celsius, with their hands and feet fully immersed in cold water for 5 minutes.

Other: Cold water

Interventions

Cold airOTHER
Cold air
Cold waterOTHER
Cold water

Eligibility Criteria

Age21 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Ethnic Chinese
  • Age between 21 to 35 years
  • Body Mass Index 18.5 to 22.9
  • Normal resting blood pressure \~120/80 mmHg
  • Normal fasting blood glucose level \<5.5 mmol/L

You may not qualify if:

  • Do not train for or partake in competitive sports
  • Do not have any major diseases
  • Not on any prescribed medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 3, 2016

Study Start

November 1, 2014

Primary Completion

November 5, 2018

Study Completion

November 5, 2018

Last Updated

May 15, 2019

Record last verified: 2019-05