NCT07128238

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

August 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 28, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

August 11, 2025

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (12)

  • 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.

    About 8 weeks.

  • Height

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

    About 8 weeks.

  • 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.

    About 8 weeks.

  • 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.

    About 8 weeks.

  • 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.

    About 8 weeks.

  • 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.

    About 8 weeks.

  • 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.

    About 8 weeks.

  • 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.

    About 7 days.

  • 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.

    About 10 weeks.

  • 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.

    About 3 days.

  • 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.

    About 8 weeks.

  • 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.

    About 3 days.

Study Arms (1)

Diet and Exercise intervention

EXPERIMENTAL

Diet intervention:Provide a fixed amount of food every day Exercise intervention:Train every day according to a specific course schedule

Behavioral: lifestyle intervention

Interventions

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.

Diet and Exercise intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

John R Speakman, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 17, 2025

Study Start

January 28, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01