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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05505240
Other study ID # TempRMR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 21, 2022
Est. completion date April 6, 2023

Study information

Verified date April 2023
Source University of Bonn
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date April 6, 2023
Est. primary completion date April 6, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Respiratory analysis at cold temperature
Respiratory analysis at an ambient temperature of 18°C
Respiratory analysis at room temperature
Respiratory analysis at an ambient temperature of 22°C
Respiratory analysis at thermoneutral temperature
Respiratory analysis at an ambient temperature of 28°C
Respiratory analysis at hot temperature
Respiratory analysis at an ambient temperature of 38°C

Locations

Country Name City State
Germany University of Bonn Bonn

Sponsors (2)

Lead Sponsor Collaborator
University of Bonn DLR German Aerospace Center

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resting Energy Expenditure Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min 20 minutes
Secondary Body core temperature Body core temperature: assessed every ten seconds during respiratory analysis (°C) 20 minutes
Secondary Body surface temperature Body surface temperature: assessed every ten seconds during respiratory analysis (°C) 20 minutes
Secondary Body composition assessed daily via bioelectrical impedance analysis after respiratory analysis (FFM (kg), FM (kg)) 5 minutes (after respiratory analysis)
Secondary Blood pressure assessed daily before respiratory analysis (mmHg) 10 minutes (at beginning of study day)
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