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Body Temperature ChangesNCT07128238

Research on "Metabolic Adaptation" in Obese People

A study testing lifestyle intervention in people with Body Temperature Changes, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Obesity has become a global public health crisis, with 810 million adults classified as obese (BMI ≥ 30 kg/m²) worldwide in 2020. This number is projected to rise to 1.53 billion by 2035. China faces a particularly severe challenge, with one of the highest rates and fastest growth in obesity prevalence globally. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Body Temperature Changes
What is being tested?
lifestyle intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
28 Jan 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI: ≥30kg/m2 Willing to participate in an 8-week weight-loss camp program

Who cannot join

  • Metabolic or cardiovascular diseases (such as diabetes) Mental disorders (such as depression and claustrophobia) Infectious diseases (such as AIDS, tuberculosis, malaria) High blood pressure Pregnant, lactating, or prepare for pregnancy Implanted or portable electro-mechanical device Taking antihypertensive or weight-loss medications

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

John R Speakman, Doctor contact

15810868669

j.speakman@abdn.ac.uk

About this study

Obesity has become a global public health crisis, with 810 million adults classified as obese (BMI ≥ 30 kg/m²) worldwide in 2020. This number is projected to rise to 1.53 billion by 2035. China faces a particularly severe challenge, with one of the highest rates and fastest growth in obesity prevalence globally. Obesity is a well-established risk factor for numerous chronic diseases, including cancer, cardiovascular disease, and diabetes. As such, weight loss is essential for improving health outcomes and preventing related complications.

Lifestyle interventions-primarily dietary modifications and physical activity-are the cornerstone of obesity treatment, aiming to reduce weight by addressing energy intake and expenditure. Accumulating evidence indicates that energy imbalance is a key driver of obesity. However, resting metabolic rate (RMR), which accounts for approximately 60-75% of total energy expenditure, often declines during lifestyle interventions due to metabolic adaptation. This adaptive decrease in RMR can undermine weight loss efforts.

While both body composition and core body temperature are known to influence RMR, their specific roles in metabolic adaptation during lifestyle interventions remain poorly understood. This study aims to investigate the individual contributions of changes in body composition and fluctuations in core body temperature to the observed reduction in RMR during such interventions. By combining body composition analysis and continuous core temperature monitoring, the study seeks to uncover mechanisms underlying metabolic adaptation and identify potential targets for enhancing weight loss strategies.

Read the detailed description

Body Composition and Related Measurements Height and Weight Measurement Fasting body weight and height will be measured using the Seca medical metric system (Seca 311231, Germany). Participants will wear a standardized disposable lab coat and stand barefoot on an electronic scale for accurate measurement. Barefoot height will be measured to the nearest millimeter using a Leicester stadiometer (Seca 217, Germany).

3D Body Scanning Participants will stand at the center of the Scanatic™ 360 3D scanning room and maintain proper posture. Trained staff will operate the scanner, sensors, and cameras to collect detailed anthropometric data, including waist and hip circumference.

Bioelectrical Impedance Analysis (BIA) Body composition will be assessed using the TANITA MC-980 device, which provides segmental weight measurements (right arm, left arm, trunk, right leg, left leg) and generates a detailed report including body weight (BW), body fat percentage (fat%), fat mass (FM), body mass index (BMI), and fat-free mass (FFM).

Dual-Energy X-ray Absorptiometry (DXA) DXA scanning (Horizon, Hologic) will be performed with participants wearing uniform disposable lab coats and without metal accessories. DXA uses a low-dose X-ray beam with two energy peaks-one absorbed by soft tissue and the other by bone-to differentiate tissue types. Software algorithms enable precise measurement of fat and fat-free mass.

BOD POD Before testing, participants will fast and avoid strenuous activity, smoking, and exercise for at least two hours. Participants will wear close-fitting swimwear (boxers for men; one-piece swimsuit for women), a swim cap, and no accessories. The BOD POD (GS-X, Cosmed) estimates body composition using air displacement, differentiating fat mass and fat-free mass based on body volume and density calculations.

Magnetic Resonance Imaging (MRI) Whole-body fat distribution will be assessed using the uMR790 MRI system (United Imaging Healthcare). No contrast agent is required. Participants will lie supine on the MRI bed while trained staff perform full-body scans from the neck to the knees using a rapid dynamic imaging sequence. The data will support the development of algorithms for body fat quantification and segmentation.

InBody Analysis InBody provides estimates of body fat percentage, muscle mass, and total body water based on the varying electrical conductivity of different tissues. Participants will stand barefoot and hold electrodes, with hands relaxed. Measurements will be recorded to one decimal place.

Deuterium Dilution Technique Total body water will be measured using the deuterium dilution technique. Participants will fast for 10 hours and provide a baseline urine sample. A dose of deuterium-labeled water (5% deuterium, 95% H₂O) will be administered based on body weight. For example, a 60 kg individual will receive 80.6 g of deuterated water.

Urine samples will be collected at baseline, 3.5 hours post-ingestion, and one week later. Samples will be stored at -20°C and analyzed at the Shenzhen Institutes of Advanced Technology, CAS. Deuterium enrichment typically increases from 150 ppm to 250 ppm and returns to baseline in 14-21 days.

Physical Activity Monitoring (GT3XP-BTLE) Daily activity will be tracked using a tri-axial accelerometer (ActiGraph GT3XP-BTLE, USA), worn continuously except during water-based activities. The device captures physical activity and sleep duration throughout the intervention.

Core Body Temperature Monitoring (e-Celsius) Core temperature will be monitored using the e-Celsius ingestible capsule (BodyCap). The capsule is swallowed under supervision and begins recording temperature approximately 4 hours after ingestion, once it reaches the intestines.

Food Intake Recording Volunteers will record food intake by photographing and weighing their meals. Provided with food scales, they will also use a card-sized object (similar to a bank card) for scale. Photos should include the food before and after eating, along with weight measurements and the card reference.

Metabolic Chamber Total energy expenditure will be measured using a metabolic chamber system (Maastricht Instruments, Netherlands), which operates on indirect calorimetry principles. The system monitors oxygen consumption and CO₂ production continuously over 24 hours. Participants will stay in the chamber from 10 p.m. on Day 1 to 7 a.m. on Day 3.

Breakfast will be provided at 20% of the daily energy requirement, following macronutrient recommendations: protein 15%, fat 25%, and carbohydrates 60%. For lunch and dinner, participants will self-select meals, which will be documented via photographs and weight measurements.

Being tested
lifestyle intervention
Medical subject headings
Body Temperature Changes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lifestyle interventionBehavioural

    This study implemented lifestyle interventions including dietary and exercise interventions. Based on the assessment of the physical condition of the volunteers, a personalized training plan is formulated and a standardized diet is provided. The entire intervention process lasts for 8 weeks.

Study groups in NCT07128238
Study groupRoleWhat they receive
Diet and Exercise interventionExperimentalDiet intervention:Provide a fixed amount of food every day Exercise intervention:Train every day according to a specific course schedule
Receives: Behavioral: lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Fasting body weight in kilograms will be measured using the Seca medical metric system (Seca 311231, Germany). Participants will wear a standardized disposable lab coat and stand barefoot on an electronic scale for accurate measurement.

    Measured: About 8 weeks.

  2. Height

    Height in centimeters will be measured to the nearest millimeter using a Leicester stadiometer (Seca 217, Germany).

    Measured: About 8 weeks.

  3. Waist circumference

    Waist circumference in centimeters will be measured by 3D Body Scanner. Participants will stand at the center of the ScanatictTM 360 3D scanning room and maintain proper posture. Trained staff will operate the scanner, sensors, and cameras to collect detailed anthropometric data, including waist and hip circumference.

    Measured: About 8 weeks.

  4. Fat mass

    Fat mass in kilograms will be measured by TANITA MC-980 device and Inbody, which provides segmental weight measurements and generates a detailed report.

    Measured: About 8 weeks.

  5. Fat-free mass

    Fat-free mass in kilograms will be measured by DXA(Dual-Energy X-ray Absorptiometry). DXA scanning (Horizon, Hologic) will be performed with participants wearing uniform disposable lab coats and without metal accessories.

    Measured: About 8 weeks.

  6. Fat%

    Fat% will be measured by BOD POD (Air Displacement Plethysmography). Before testing, participants will fast and avoid strenuous activity, smoking, and exercise for at least two hours. Participants will wear close-fitting swimwear (boxers for men; one-piece swimsuit for women), a swim cap, and no accessories. The BOD POD (GS-X, Cosmed) estimates body composition using air displacement, differentiating fat mass and fat-free mass based on body volume and density calculations.

    Measured: About 8 weeks.

  7. Total body volume

    Total body volume in liters will be measured by MRI (United Imaging uMR790). Whole-body fat distribution will be assessed using the uMR790 MRI system (United Imaging Healthcare). No contrast agent is required. Participants will lie supine on the MRI bed while trained staff perform full-body scans from the neck to the knees using a rapid dynamic imaging sequence.

    Measured: About 8 weeks.

  8. Total body water

    Total body water in kilograms will be measured by deuterium dilution technique. Participants will fast for 10 hours and provide a baseline urine sample. A dose of deuterium-labeled water (5%deuterium, 95% H2O) will be administered based on body weight. For example, a 60 kg individual will receive 80.6 g of deuterated water.

    Urine samples will be collected at baseline, 3.5 hours post-ingestion, and one week later. Samples will be stored at -20℃ and analyzed at the Shenzhen Institutes of Advanced Technology, CAS. Deuterium enrichment typically increases from 150 ppm to 250 ppm and returns to baseline in 14-21 days.

    Measured: About 7 days.

  9. Physical Activity

    Daily activity will be tracked using a tri-axial accelerometer (ActiGraph GT3XP- BTLE, USA), worn continuously except during water-based activities. The device captures physical activity and sleep duration throughout the intervention.

    Measured: About 10 weeks.

  10. Core Body Temperature

    Core body temperature in degree centigrade will be measured by the e-Celsius ingestible capsule (BodyCap). The capsule is swallowed uner supervision and begins recording temperature approximately 4 hours after ingestion, once it reaches the intestines.

    Measured: About 3 days.

  11. Food Intake

    Food intake in grams will be measured by food scales. Volunteers will record food intake by photographing and weighing their meals. Provided with food scales, they will also use a card-sized object (similar to a bank card) for scale. Photos should include the food before and after eating, along with weight measurements and the card reference.

    Measured: About 8 weeks.

  12. Total energy expenditure

    Total energy expenditure will be measured using a metabolic chamber system (Maastricht Instruments, Netherlands), which operates on indirect calorimetry principles. The system monitors oxygen consumption and CO2 production continuously over 24 hours. Participants will stay in the chamber from 10 p.m. on Day 1 to 7 a.m. on Day 3.

    Breakfast will be provided at 20% of the daily energy requirement, following macronutrient recommendations: protein 15%, fat 25%, and carbohydrates 60%. For lunch and dinner, participants will self-select meals, which will be documented via photographs and weight measurements.

    Measured: About 3 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start28 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07128238
Sponsor's protocol ID
SIAT-IRB-250415-H0976
Status last verified
Jan 2026
First submitted
11 Aug 2025
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing lifestyle intervention in people with Body Temperature Changes, run by Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences.

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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact John R Speakman, Doctor (15810868669, j.speakman@abdn.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: About 8 weeks.). The study lists 12 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 22 Jan 2026.

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