The Interaction Between Resting Metabolic Rate, Physical Activity and Thyroid Hormone in Females

August 11, 2025 updated by: John R. Speakman, Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Sanduni S De Alwis, Bachelor
  • Phone Number: +86 19065020853
  • Email: alwis@siat.ac.cn

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study participants are adult healthy females.

Description

Inclusion Criteria:

  • Female age ≥18;
  • BMI≥18.5

Exclusion Criteria:

  • 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;

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Measurements will take at the first day of the visit
Height
Time Frame: Measurements will take at the first day of the visit
Measured by seca 217 stable stadiometer. Subjects wearing no shoes.
Measurements will take at the first day of the visit
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.
Measurements will take at the first day of the visit
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.
Measurements will take at the first day of the visit.
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).
Measurements will take at the first day of the visit
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).
Measurements will take at the first day of the visit
Bone mass
Time Frame: Measurements will take at the first day of the visit
Bone mass will be measured by DXA (Hologic).
Measurements will take at the first day of the visit
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.
Measurements last for 14 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.
Blood samples will collect at the first day of the visit.
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.
measurements will take at the first day of visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total energy expenditure
Time Frame: Measurements take for 14 days
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.
Measurements take for 14 days
Total energy expenditure
Time Frame: Measurements take at the first day of the visit
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.
Measurements take at the first day of the visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: John R Speakman, PhD, Shenzhen Institute of Advanced Technology, CAS

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIAT-IRB-240415-H0718

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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