NCT03095846

Brief Summary

This study investigates cold-induced brown fat activation in winter swimmers and not-winter swimmers by skin temperature measures assessed with infra red thermography imaging and skin temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling intervention and thermoneutral intervention for comparison of energy expenditure and skin temperatures at the supraclavicular area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 6, 2017

Last Update Submit

March 23, 2018

Conditions

Adipose TissueBrown Adipose TissueBrown FatUncoupling Protein 1AdipokinesProteomicsInfra-red ThermographyBATWinter SwimmersType2 DiabetesProteins

Outcome Measures

Primary Outcomes (1)

  • 5. Difference in brown adipose tissue (BAT) activity after cooling between Winter Swimmers (WS) and No-Winter Swimmers (NWS).

    BAT activity is measured by skin temperature in the supraclavicular BAT depot using infrared thermography imaging. Difference between peak temperature change (peak temperature minus baseline temperature) during 2 hours of cooling is calculated.

    Difference in peak temperature after 2 hours of cooling.

Secondary Outcomes (2)

  • Difference in glucose control between WS and NWS.

    Difference in glucose control between WS and NWS after a 2 hours glucose tolerance test under thermoneutral conditions.

  • Difference in resting energy expenditure after cooling versus no cooling

    Difference in resting energy expenditure after 2 hours of cooling versus 2 hours of no cooling.

Study Arms (2)

Winter Swimmers

EXPERIMENTAL

Individualized cooling protocol

Procedure: Cooling

Not-winter Swimmers

EXPERIMENTAL

Individualized cooling protocol

Procedure: Cooling

Interventions

CoolingPROCEDURE

Individualized cooling protocol

Also known as: Cold activation, Cold stimulation, Cold activation of BAT
Not-winter SwimmersWinter Swimmers

Eligibility Criteria

Age18 Years - 35 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years. Men Caucasian white Body Mass Index 19-25 kg/m2. Moderate physical activity level (not more than 8-10 hours of training pr. Week) Ability to give informed consent. Ability to follow verbal and written instructions in Danish. Body fat percent under 21% measured at the pre-examination day. Winter swimmers: Min. 2 swim/ week. Swimming in winter-season in open water outdoor in Denmark from September/October until study start in March.
  • Not-winter swimmers: Not winter-swimmers or taken cold showers on a regular basis.

You may not qualify if:

  • Chronic diseases: Hormonal: Metabolic Diseases mb. Graves, hypothyroidism, myxedema and goiter. Diabetes Melitus, Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years.
  • Tobacco, marijuana or intravenous drug use within 1 year of screening. Dieting, recent weight loss (\>3 kg within 3 month) or a history of an eating disorder.
  • Dietary supplements. History of depression, psychosis, or other psychiatric illness requiring hospitalization.
  • Alcohol consumption \>14 units/week. History of alcohol abuse within the past 3 years. Known liver disease or elevated liver biomarkers more than 2 times upper normal levels in the preliminary investigation.
  • Known kidney disease or elevated kidney biomarkers, in the preliminary investigation.
  • Use of daily medications, except for seasonal use of antihistamines. Diagnosed sleep disturbances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Inflammation and Metabolism/ Center for Physical Activity Research

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Cool-Down Exercise

Intervention Hierarchy (Ancestors)

Post-Exercise Recovery TechniquesPhysical Therapy ModalitiesTherapeuticsRehabilitationExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Susanna Søberg, MSc.

    Center for Inflammation and Metabolism/Center for Physical Activity Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 30, 2017

Study Start

April 2, 2017

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 27, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)