NCT07137520

Brief Summary

The goal of this observational study is to learn about the effects of physical activity in adult on metabolic response. The main question it aims to answer is:

  • if physical activity is unlimited to increase the total energy expenditure (TEE)? Participants will engage in the following measurements:
  • Record their daily physical activity by GT3X.
  • Measure TEE by doubly-labeled water (DLW) method
  • Measure basal energy expenditure(BEE) and thermic effect of food(TEF) by respiratory chamber

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress30%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

April 3, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

April 3, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

Metabolic responseEnergy expenditurePhysical fitness

Outcome Measures

Primary Outcomes (6)

  • Differences in total energy expenditure (TEE) measured by the doubly labeled water (DLW) method across experimental groups

    \- The change in TEE will be evaluated using the DLW. Urine samples from all participants in the DLW subset will be stored at -20℃ and shipped on dry ice for analysis in the laboratory of Dr. John Speakman at the University of Aberdeen, or the Shenzhen Institutes of Advanced Technology, Chinese academy of sciences. Isotopes will be measured in 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.

    14days

  • Differences in non-exercise physical activity across experimental groups

    \- Physical activity of the participants will be recorded using GT3X accelerometer worn near the hip for a consecutive period of 14 days.

    14days

  • Differences in resting energy expenditure (REE) measured by respiratory chamber across experimental groups

    \- REE will be evaluated by respiratory chamber.

    1 day

  • Differences in thermic effect of food (TEF) measured by respiratory chamber across experimental groups

    \- TEF will be evaluated by respiratory chamber.

    1 day

  • Differences in exercise energy expenditure (EEE) measured by COSMED across experimental groups

    \- EEE will be evaluated using an indirect calorimetry COSMED.

    1 hour

  • Differences in food intake across experimental groups

    Photographic and food weighing methods to record food intake for two random days throughout the period of DLW measurement

    2 days

Secondary Outcomes (7)

  • Differences in sedentary time measured by GT3X accelerometer across experimental groups

    14 days

  • Differences in glucose across experimental groups

    7 days

  • Differences in fat mass across experimental groups

    10 minutes

  • Differences in fat-free mass across experimental groups

    2 minutes

  • Differences in bone mass intensity across experimental groups

    7 minutes

  • +2 more secondary outcomes

Study Arms (3)

Sedentary group

Godin scale score ≥ 24

Other: Observation without intervention

Moderately active group

14≥ Godin scale score ≥ 23

Other: Observation without intervention

Active group

Godin scale score \<14

Other: Observation without intervention

Interventions

Observation without intervention

Active groupModerately active groupSedentary group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Residents of Shenzhen, Guangzhou, China

You may qualify if:

  • BMI ≥ 18.5 kg/m2

You may not qualify if:

  • Individuals who have undergone major surgery in the past 6 months (excluding tooth extraction);
  • Individuals with severe metabolic and cardiovascular diseases such as diabetes, hypoglycemia, and hypertension;
  • Individuals with exercise-related injuries, including joint diseases and fractures;
  • Individuals diagnosed with infectious diseases such as HIV, tuberculosis, malaria, etc.;
  • Individuals with mental and neurological disorders including anorexia nervosa;
  • Individuals who have attempted weight loss or gain through various methods in the past three months;
  • Individuals in preconception, pregnancy, and lactation periods;
  • Individuals with autism and those with metal implants in their bodies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institutes of Advanced Technology,Chinese Academy of Sciences

Shenzhen, Guangdong, China

Location

Related Publications (2)

  • Speakman JR, Yamada Y, Sagayama H, Berman ESF, Ainslie PN, Andersen LF, Anderson LJ, Arab L, Baddou I, Bedu-Addo K, Blaak EE, Blanc S, Bonomi AG, Bouten CVC, Bovet P, Buchowski MS, Butte NF, Camps SGJA, Close GL, Cooper JA, Creasy SA, Das SK, Cooper R, Dugas LR, Ebbeling CB, Ekelund U, Entringer S, Forrester T, Fudge BW, Goris AH, Gurven M, Hambly C, El Hamdouchi A, Hoos MB, Hu S, Joonas N, Joosen AM, Katzmarzyk P, Kempen KP, Kimura M, Kraus WE, Kushner RF, Lambert EV, Leonard WR, Lessan N, Ludwig DS, Martin CK, Medin AC, Meijer EP, Morehen JC, Morton JP, Neuhouser ML, Nicklas TA, Ojiambo RM, Pietilainen KH, Pitsiladis YP, Plange-Rhule J, Plasqui G, Prentice RL, Rabinovich RA, Racette SB, Raichlen DA, Ravussin E, Reynolds RM, Roberts SB, Schuit AJ, Sjodin AM, Stice E, Urlacher SS, Valenti G, Van Etten LM, Van Mil EA, Wells JCK, Wilson G, Wood BM, Yanovski J, Yoshida T, Zhang X, Murphy-Alford AJ, Loechl CU, Melanson EL, Luke AH, Pontzer H, Rood J, Schoeller DA, Westerterp KR, Wong WW; IAEA DLW database group. A standard calculation methodology for human doubly labeled water studies. Cell Rep Med. 2021 Feb 16;2(2):100203. doi: 10.1016/j.xcrm.2021.100203. eCollection 2021 Feb 16.

    PMID: 33665639BACKGROUND
  • Pontzer H, Durazo-Arvizu R, Dugas LR, Plange-Rhule J, Bovet P, Forrester TE, Lambert EV, Cooper RS, Schoeller DA, Luke A. Constrained Total Energy Expenditure and Metabolic Adaptation to Physical Activity in Adult Humans. Curr Biol. 2016 Feb 8;26(3):410-7. doi: 10.1016/j.cub.2015.12.046. Epub 2016 Jan 28.

    PMID: 26832439BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

* Whole blood * Feces * Urine

MeSH Terms

Conditions

Motor Activity

Interventions

ObservationMethods

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • John R Speakman, PhD

    Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John R Speakman, PhD

CONTACT

Xinyi BI, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 3, 2025

First Posted

August 22, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

August 22, 2025

Record last verified: 2025-08

Locations