Influence of Ambient Temperature on Resting Energy Expenditure of Healthy Adults

Resting Energy Expenditure Clinical Trial

Official title:

Influence of Ambient Temperature on Resting Energy Expenditure of Metabolically Healthy Men and Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05505240
• Other study ID #: TempRMR
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Resting Energy Expenditure

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)