NCT06377943

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 29, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

April 17, 2024

Last Update Submit

August 11, 2025

Conditions

Outcome Measures

Primary Outcomes (10)

  • 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.

    Measurements will take at the first day of the visit

  • Height

    Measured by seca 217 stable stadiometer. Subjects wearing no shoes.

    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.

    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).

    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).

    Measurements will take at the first day of the visit

  • Bone mass

    Bone mass will be measured by DXA (Hologic).

    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.

    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.

    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.

    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.

    measurements will take at the first day of visit

Secondary Outcomes (2)

  • Total energy expenditure

    Measurements take for 14 days

  • Total energy expenditure

    Measurements take at the first day of the visit

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study participants are adult healthy females.

You may qualify if:

  • Female age ≥18;
  • BMI≥18.5

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences

Shenzhen, Guangdong, 518000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples and Urine samples

MeSH Terms

Conditions

Thyroid DiseasesMotor Activity

Condition Hierarchy (Ancestors)

Endocrine System DiseasesBehavior

Study Officials

  • John R Speakman, PhD

    Shenzhen Institute of Advanced Technology, CAS

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, chief researcher

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 22, 2024

Study Start

June 29, 2024

Primary Completion

October 31, 2024

Study Completion

January 31, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Locations