Resting Energy ExpenditureNCT05505240
Influence of Ambient Temperature on Resting Energy Expenditure of Healthy Adults
A study testing Respiratory analysis at cold temperature, Respiratory analysis at room temperature and Respiratory analysis at thermoneutral temperature in people with Resting Energy Expenditure, run by University of Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Resting Energy Expenditure
- What is being tested?
- Respiratory analysis at cold temperature, Respiratory analysis at room temperature and Respiratory analysis at thermoneutral temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteGermany
- Study dates
- 21 Nov 2022to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 18,5 - 24,9 kg/m2
- metabolically healthy
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Resting Energy Expenditure
- Being tested
- Respiratory analysis at cold temperature, Respiratory analysis at room temperature, Respiratory analysis at thermoneutral temperature, Respiratory analysis at hot temperature
- Keywords
- Resting energy expenditure, Resting metabolic rate, Ambient temperature, Environmental temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory analysis at cold temperatureOther
Respiratory analysis at an ambient temperature of 18°C
Respiratory analysis at room temperatureOther
Respiratory analysis at an ambient temperature of 22°C
Respiratory analysis at thermoneutral temperatureOther
Respiratory analysis at an ambient temperature of 28°C
Respiratory analysis at hot temperatureOther
Respiratory analysis at an ambient temperature of 38°C
| Study group | Role | What they receive |
|---|---|---|
| Cold temperature | Experimental | 18°C Receives: Other: Respiratory analysis at cold temperature |
| Room temperature | Experimental | 22°C Receives: Other: Respiratory analysis at room temperature |
| Thermoneutral temperature | Experimental | 28°C Receives: Other: Respiratory analysis at thermoneutral temperature |
| Hot temperature | Experimental | 38°C Receives: Other: Respiratory analysis at hot temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Energy Expenditure
Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min
Measured: 20 minutes
Secondary outcomes (4)
Body core temperature
Body core temperature: assessed every ten seconds during respiratory analysis (°C)
Measured: 20 minutes
Body surface temperature
Body surface temperature: assessed every ten seconds during respiratory analysis (°C)
Measured: 20 minutes
Body composition
assessed daily via bioelectrical impedance analysis after respiratory analysis (FFM (kg), FM (kg))
Measured: 5 minutes (after respiratory analysis)
Blood pressure
assessed daily before respiratory analysis (mmHg)
Measured: 10 minutes (at beginning of study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start21 Nov 2022
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resting Energy ExpenditureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- DLR German Aerospace Center
- Responsible party
- Principal investigator, Prof. Dr. Sarah Egert, University of Bonn
- Investigators
- Sarah Egert, Prof. PhD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505240
- Sponsor's protocol ID
- TempRMR
- Status last verified
- Apr 2023
- First submitted
- 15 Aug 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Henkel S, Frings-Meuthen P, Diekmann C, Coenen M, Stoffel-Wagner B, Nemeth R, Pesta D, Egert S. Influence of Ambient Temperature on Resting Energy Expenditure in Metabolically Healthy Males and Females. J Nutr. 2025 Mar;155(3):862-870. doi: 10.1016/j.tjnut.2025.01.013. Epub 2025 Jan 13.
PubMed 39814140
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ambient Temperature on Resting Energy Expenditure of Metabolically Healthy Men and Women
- ClinicalTrials.gov ID
- NCT05505240
- Acronym / sponsor ID
- TempRMR
- Conditions
- Resting Energy Expenditure
- Keywords
- Resting energy expenditure, Resting metabolic rate, Ambient temperature, Environmental temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Collaborators
- DLR German Aerospace Center
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cold temperature | Experimental | Other: Respiratory analysis at cold temperature18°C |
| Room temperature | Experimental | Other: Respiratory analysis at room temperature22°C |
| Thermoneutral temperature | Experimental | Other: Respiratory analysis at thermoneutral temperature28°C |
| Hot temperature | Experimental | Other: Respiratory analysis at hot temperature38°C |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI: 18,5 - 24,9 kg/m2
- metabolically healthy
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory analysis at cold temperatureRespiratory analysis at an ambient temperature of 18°C | Other | Cold temperature |
| Respiratory analysis at room temperatureRespiratory analysis at an ambient temperature of 22°C | Other | Room temperature |
| Respiratory analysis at thermoneutral temperatureRespiratory analysis at an ambient temperature of 28°C | Other | Thermoneutral temperature |
| Respiratory analysis at hot temperatureRespiratory analysis at an ambient temperature of 38°C | Other | Hot temperature |
Primary outcome
Resting Energy Expenditure
Time frame: 20 minutes
Volume of inhaled oxygen (VO2) in L/min and exhaled carbon dioxide (VCO2) in L/min
4 secondary outcomes
Body core temperature
Time frame: 20 minutes
Body surface temperature
Time frame: 20 minutes
Body composition
Time frame: 5 minutes (after respiratory analysis)
Blood pressure
Time frame: 10 minutes (at beginning of study day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Derived from this study: PubMed 39814140Henkel S, Frings-Meuthen P, Diekmann C, Coenen M, Stoffel-Wagner B, Nemeth R, Pesta D, Egert S. Influence of Ambient Temperature on Resting Energy Expenditure in Metabolically Healthy Males and Females. J Nutr. 2025 Mar;155(3):862-870. doi: 10.1016/j.tjnut.2025.01.013. Epub 2025 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Egert, Prof. PhD principal investigator
University of Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory analysis at cold temperature, Respiratory analysis at room temperature and Respiratory analysis at thermoneutral temperature in people with Resting Energy Expenditure, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Energy Expenditure (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05505240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.