- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05505240
Influence of Ambient Temperature on Resting Energy Expenditure of Healthy Adults
April 11, 2023 updated by: Prof. Dr. Sarah Egert, University of Bonn
Influence of Ambient Temperature on Resting Energy Expenditure of Metabolically Healthy Men and Women
The aim of this study is to investigate the influence of four different ambient temperatures (18, 22, 28, 38°C) on the resting energy expenditure of healthy adults by respiratory gas analysis.
It is assumed that the resting energy expenditure is higher at 18°C and 38°C than at the temperatures in between.
Study Overview
Status
Completed
Conditions
Detailed Description
In a crossover-design, 32 healthy men and women participate in four interventions.
Each intervention includes a measurement of the resting energy expenditure by respiratory gas analysis at a different ambient temperature (18,22, 28 and 38°C).
During this time body core- and surface temperature are assessed, as well as body composition via bioelectrical impedance analysis.
For each participant the four individual study days take place in a randomized order on consecutive weekdays within a week.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bonn, Germany, 53115
- University of Bonn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- BMI: 18,5 - 24,9 kg/m2
- metabolically healthy
Exclusion Criteria
- smoking
- low or high blood pressure
- dyslipidemia
- insulin resistance or diabetes mellitus type 1 or type 2
- gastrointestinal diseases (e.g. food intolerances or allergies)
- liver, kidney and/or thyroid diseases
- hepatitis B or C, HIV Infection
- chronic inflammatory diseases
- disordered eating
- psychological diseases
- alcohol and/or drug abuse
- use of medication
- pregnancy or lactating
- participation in another intervention study
- women: irregular menstrual cycle
- more than 6 h of sports per week
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cold temperature
18°C
|
Respiratory analysis at an ambient temperature of 18°C
|
|
Experimental: Room temperature
22°C
|
Respiratory analysis at an ambient temperature of 22°C
|
|
Experimental: Thermoneutral temperature
28°C
|
Respiratory analysis at an ambient temperature of 28°C
|
|
Experimental: Hot temperature
38°C
|
Respiratory analysis at an ambient temperature of 38°C
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resting Energy Expenditure
Time Frame: 20 minutes
|
Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body core temperature
Time Frame: 20 minutes
|
Body core temperature: assessed every ten seconds during respiratory analysis (°C)
|
20 minutes
|
|
Body surface temperature
Time Frame: 20 minutes
|
Body surface temperature: assessed every ten seconds during respiratory analysis (°C)
|
20 minutes
|
|
Body composition
Time Frame: 5 minutes (after respiratory analysis)
|
assessed daily via bioelectrical impedance analysis after respiratory analysis (FFM (kg), FM (kg))
|
5 minutes (after respiratory analysis)
|
|
Blood pressure
Time Frame: 10 minutes (at beginning of study day)
|
assessed daily before respiratory analysis (mmHg)
|
10 minutes (at beginning of study day)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Egert, Prof. PhD, University of Bonn
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2022
Primary Completion (Actual)
April 6, 2023
Study Completion (Actual)
April 6, 2023
Study Registration Dates
First Submitted
August 15, 2022
First Submitted That Met QC Criteria
August 15, 2022
First Posted (Actual)
August 17, 2022
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 11, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TempRMR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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