ThyroidNCT06377943
The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females
An observational study of Thyroid and Physical Activities, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
Trial summary
This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH). TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid, Physical Activities, Resting Energy Expenditure
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 29 Jun 2024to 31 Jan 2025
- Phase
- Observational
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study participants are adult healthy females.
Who may be able to join
- Female age ≥18;
- BMI≥18.5
Who cannot join
- Intended weight change exceeding 2kg within the past three months;
- Having any special medical diets or having eating disorders;
- Pregnant women or breastfeeding women;
- People who have metal implants in their bodies;
- Patients with metabolic diseases, infectious diseases, and genetic disorders such as hypothyroidism, and hyperthyroidism;
- Patients with a personal or family history of medullary thyroid carcinoma (MTC), or patients with rare type 2 multiple endocrine tumor syndrome (MEN2); People with a fear of needles (Trypanophobia), claustrophobia; People who are fear of blood (Hemophobia) or pathological hypotension;
Trial locations and contacts
1 site in 1 country.
China1 site
Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences
Shenzhen, Guangdong, 518000
About this study
This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH). TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones. This is the reason for individuals who suffer from thyroid disorders show abnormal metabolism. Recently it was suggested that interindividual variations in thyroid hormone levels also influence daily physical activity.
Read the detailed description
In this study, investigators will recruit adult females with a BMI ≥18.5. After the screening process, eligible volunteers will undergo certain measurements including body composition, resting metabolism daily physical activity, thyroid hormone levels, and total energy expenditure. The investigators will access the changes in resting metabolism and daily physical activities with the differences in thyroid hormone levels.
- Conditions
- Thyroid, Physical Activities, Resting Energy Expenditure
- Medical subject headings
- Thyroid Diseases, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Subjects will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes.
Measured: Measurements will take at the first day of the visit
Height
Measured by seca 217 stable stadiometer. Subjects wearing no shoes.
Measured: Measurements will take at the first day of the visit
Waist and Hip circumferences
Waist and Hip circumferences will be measured using a whole body laser scanner.
Measured: Measurements will take at the first day of the visit
Fat mass
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ) or DXA (Hologic).
Measured: Measurements will take at the first day of the visit
Far free mass
Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980) or DXA (Hologic).
Measured: Measurements will take at the first day of the visit
Bone mass
Bone mass will be measured by DXA (Hologic).
Measured: Measurements will take at the first day of the visit
Resting Metabolism
Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The subject attends the lab after an overnight fast. The person lies down on a flatbed and the hood is placed over their head. Metabolic rates (oxygen consumption and CO2 production) are monitored for 30 minutes. Calorimeters will be assessed with a turbine test to ensure the accuracy of measurements. Validation via an alcohol burn will be performed monthly.
Measured: Measurements will take at the first day of the visit.
Physical activity
Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 10 hours. For a valid measure, the goal is to get at least 2 weekday and 2 weekend days.
Measured: Measurements last for 14 days
Thyroid hormone
Nurses will collect the blood samples on day 1. Levels of circulating thyroid hormones will be measured using radio immunoassay.
Measured: Blood samples will collect at the first day of the visit.
Resting Metabolism
The whole room calorimeter/metabolic chamber (OMNICAL, Maastricht instrument) will be used to measure resting metabolic rate. The metabolic chamber is a sealed room with a continuous gas supply (CO2- 0.80×10-2, O2 -18.00×10-2), providing subjects with 24-hour energy expenditure data. The total energy expenditure of the subjects in MJ/day was plotted against time in 30-minute intervals over 24 hours. The lowest and most stable energy expenditure during sleep time was considered the RMR of the subjects, which occurred from 2:00 am to 5:00 am.
Measured: measurements will take at the first day of visit
Secondary outcomes (2)
Total energy expenditure
Total energy expenditure (TEE) will be measured using the DLW method. Urine samples from all participants in the DLW subset will be stored at -20 oC and analyzed in the laboratory of Dr. John Speakman at the Shenzhen Institute of Advanced Technology, Chinese Academy of sciences. Isotopes will be measured in a benchtop near-infrared isotope gas analyzer, and mean CO2 production will be calculated from isotope ratios using the recently derived equation (Speakman et al 2021: Cell reports medicine). TEE will then be calculated using mean CO2 production using the Weir equation.
Measured: Measurements take for 14 days
Total energy expenditure
Total energy expenditure will be measured using the whole room calorimeter / metabolic chamber (OMNICAL, Maastricht instrument). The metabolic chamber is a sealed room with a continuous gas supply (CO2- 0.80×10-2, O2 -18.00×10-2), providing subjects with 24-hour energy expenditure data. The total energy expenditure was calculated by averaging the chamber's gaseous exchange using a 24-hour time window between 11.30 am and the next day around 3.00 pm.
Measured: Measurements take at the first day of the visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start29 Jun 2024
- Primary completion31 Oct 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John R. Speakman, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
- Investigators
- John R Speakman, PhD, Study chair, Shenzhen Institute of Advanced Technology, CAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377943
- Sponsor's protocol ID
- SIAT-IRB-240415-H0718
- Status last verified
- Aug 2025
- First submitted
- 17 Apr 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females
- ClinicalTrials.gov ID
- NCT06377943
- Acronym / sponsor ID
- SIAT-IRB-240415-H0718
- Conditions
- Thyroid, Physical Activities, Resting Energy Expenditure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shenzhen Institutes of Advanced Technology ,Chinese Academy of SciencesUniversity, hospital or other
- Study start
- 29 Jun 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 22 Apr 2024 (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.
This Study is focused on the interaction between resting metabolic rate (RMR), physical activity (PA), and thyroid hormones (TH). TH controls almost all the cell activities of the body so, it is known as one of the major regulatory hormones. This is the reason for individuals who suffer from thyroid disorders show abnormal metabolism. Recently it was suggested that interindividual variations in thyroid hormone levels also influence daily physical activity.
Detailed description
In this study, investigators will recruit adult females with a BMI ≥18.5. After the screening process, eligible volunteers will undergo certain measurements including body composition, resting metabolism daily physical activity, thyroid hormone levels, and total energy expenditure. The investigators will access the changes in resting metabolism and daily physical activities with the differences in thyroid hormone levels.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study participants are adult healthy females.
Key inclusion criteria (2 listed)
- Female age ≥18;
- BMI≥18.5
Key exclusion criteria (6 listed)
- Intended weight change exceeding 2kg within the past three months;
- Having any special medical diets or having eating disorders;
- Pregnant women or breastfeeding women;
- People who have metal implants in their bodies;
- Patients with metabolic diseases, infectious diseases, and genetic disorders such as hypothyroidism, and hyperthyroidism;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body weight
Time frame: Measurements will take at the first day of the visit
Subjects will be asked to fast overnight and weight will be measured using a calibrated Seca body weight scale first thing in the morning on subjects wearing light clothes and no shoes.
Height
Time frame: Measurements will take at the first day of the visit
Measured by seca 217 stable stadiometer. Subjects wearing no shoes.
Waist and Hip circumferences
Time frame: Measurements will take at the first day of the visit
Waist and Hip circumferences will be measured using a whole body laser scanner.
Fat mass
Time frame: Measurements will take at the first day of the visit
Fat mass will be measured by Magnetic Resonance Imaging (Shanghai united imaging, uMR 790 ) or DXA (Hologic).
Far free mass
Time frame: Measurements will take at the first day of the visit
Fat free mass will be measured by Bioimpedance Analysis (Tanita, MC-980) or DXA (Hologic).
Bone mass
Time frame: Measurements will take at the first day of the visit
Bone mass will be measured by DXA (Hologic).
Resting Metabolism
Time frame: Measurements will take at the first day of the visit.
Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The subject attends the lab after an overnight fast. The person lies down on a flatbed and the hood is placed over their head. Metabolic rates (oxygen consumption and CO2 production) are monitored for 30 minutes. Calorimeters will be assessed with a turbine test to ensure the accuracy of measurements. Validation via an alcohol burn will be performed monthly.
Physical activity
Time frame: Measurements last for 14 days
Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days. The monitor should not be worn while bathing or swimming. The first day is discarded along with any day where the wear time is less than 10 hours. For a valid measure, the goal is to get at least 2 weekday and 2 weekend days.
Thyroid hormone
Time frame: Blood samples will collect at the first day of the visit.
Nurses will collect the blood samples on day 1. Levels of circulating thyroid hormones will be measured using radio immunoassay.
Resting Metabolism
Time frame: measurements will take at the first day of visit
The whole room calorimeter/metabolic chamber (OMNICAL, Maastricht instrument) will be used to measure resting metabolic rate. The metabolic chamber is a sealed room with a continuous gas supply (CO2- 0.80×10-2, O2 -18.00×10-2), providing subjects with 24-hour energy expenditure data. The total energy expenditure of the subjects in MJ/day was plotted against time in 30-minute intervals over 24 hours. The lowest and most stable energy expenditure during sleep time was considered the RMR of the subjects, which occurred from 2:00 am to 5:00 am.
2 secondary outcomes
Total energy expenditure
Time frame: Measurements take for 14 days
Total energy expenditure
Time frame: Measurements take at the first day of the visit
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 15 Aug 2025.
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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.
John R Speakman, PhD study chair
Shenzhen Institute of Advanced Technology, CAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid and Physical Activities, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences at 1 site in China.
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 6 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 15 Aug 2025. 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 China. 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?
Body weight (time frame: Measurements will take at the first day of the visit). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025; AzTrials last refreshed its copy on 27 Oct 2026.