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

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

Not yet recruiting

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

Observational

Enrollment (Estimated)

50

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 Backup

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

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

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

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
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 ).
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).
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 DEXA (Hologic).
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.
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 7 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 12 hours. For a valid measure, the goal is to get 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 immune assay.
Blood samples will collect at the first day of the visit.

Secondary Outcome Measures

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

Collaborators and Investigators

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

Investigators

  • 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 (Estimated)

May 1, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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

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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