NCT06432517

Brief Summary

Excess energy, obesity and obesity-related diseases are important global health issues. Although it is known that obesity is an issue of energy balance, the components of energy expenditure seem to be inter-related in complex non-additive ways. The aim of this study is to explore the downstream impacts of exercise on short term changes in both expenditure and energy intake. The primary question the investigators are asking is whether moderate to high intensity exercise influences the basal energy expenditure and/or energy intake/macronutrient preference in young adult males? (A similar study will be performed on females in a different registration). The investigators will use a specially designed feeding table to measure energy intake and macronutrient intake, which is easy to quantify intake compensation. Basal metabolism will be measured by hood indirect calorimetry. The investigators will explore the factors that influence the level of compensation in expenditure and intake, in particular body composition. Participants will be asked to come to the lab after 10 hours fast for body composition tests including Dual Energy X-ray Absorptiometry(DXA), Magnetic Resonance Image(MRI) and Bioelectrical Impedance Analysis(BIA). They will then be asked (not) to do 30 minutes of moderate-to-vigorous exercise after an energy-limiting breakfast, during which metabolic rate levels and changes in dietary composition will be recorded by gas exchange and standardized buffet. In addition, participants' subjective hunger and preferences will also be recorded by questionnaires. Venous blood will be collected to measure metabolic and hormone factors, blood glucose will be measured by Continuous Blood Glucose Monitor (CGM).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

April 2, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

April 2, 2024

Last Update Submit

August 11, 2025

Conditions

Keywords

Energy compensationEnergy balanceFood Preferences

Outcome Measures

Primary Outcomes (3)

  • Macronutrient preference

    Macronutrients preference will be recorded by the feeding table, macronutrient preference will be calculated in percentage(%).

    During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.

  • Energy intake

    Response on standard feeding table, the food consumption will be recorded continuously by balances underneath each food dish. The total energy intake will be calculated in kilojoule (KJ).

    During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.

  • Basal metabolic rate

    Resting energy expenditure will be measured using indirect calorimetry via a respiratory hood system (Cosmed). The subject attends in the lab after an overnight fast. The person lies down on a flat bed and the hood is placed over their head. Metabolic rate (oxygen consumption and carbon dioxide production) are monitored for 40 minutes. The last 10 minutes is used as the measurement. Calorimeters will be assessed with a turbine test to ensure accuracy of measurements. Validation via an alcohol burn will be performed monthly.

    The detection time spans over two days, the control day and the exercise day, from 8:00 am to 5:00 pm, with tests being conducted every hour and each test lasting for half an hour.

Secondary Outcomes (15)

  • Blood glucose

    Wear it for a total of 4 consecutive days, including the physical examination day, the control day, the exercise day, and the day following the exercise day.

  • Physical activity

    Wear it for 14 days from the physical examination day

  • Ambient temperature

    Wear it for 14 days from the physical examination day

  • Circulating Biochemical indexes and hormones

    The venous blood of volunteers will be collected 10 times on control and exercise days. (Control day: fasting, 1,2,3,4 hours after breakfast and 2 hours after lunch. Exercise day: 0,1,2 hours after exercise and 2 hours after lunch)

  • Exercise

    30 minutes after breakfast(only on the exercise day), it last for 39 minutes, 30 minutes at 100 watts and 9 minutes at 25 watts.

  • +10 more secondary outcomes

Study Arms (1)

Moderate to high intensity exercise

EXPERIMENTAL

BMI≥18.5, age between 18-40 years old, 81subjects.

Other: Power Bike(Ergoselect 100P)

Interventions

Changes in the participants' energy balance will be measured through moderate to high intensity exercise. Observation of food intake, body composition, metabolic rate, food assimilation rate.

Moderate to high intensity exercise

Eligibility Criteria

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

You may qualify if:

  • Healthy adults (men)
  • years old
  • BMI (body mass index)≥18.5 kg/m2

You may not qualify if:

  • Those who have undergone surgery in the past 6 months.
  • People are requiring long-term medication.
  • People have metabolic diseases, like diabetes, hypoglycemia, gout, osteoporosis, et al.
  • People have digestive diseases, like gastric ulcer, pancreatitis, Intestinal obstruction, et al.
  • People have sports injury, like fracture, Joint injury, et al.
  • Those who have recently lost weight for various medical reasons (e.g. cancer, etc.).
  • People are losing weight by tablets.
  • People are suffering from infectious diseases (e.g. HIV, etc.)
  • People have blood phobia, pathological hypo or hyper tension.
  • People with impaired glucose tolerance.
  • Those who are afflicted with claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Institute of Advanced Technology

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Motor ActivityFood Preferences

Condition Hierarchy (Ancestors)

BehaviorFeeding Behavior

Study Officials

  • John Speakman

    Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences

    STUDY CHAIR

Central Study Contacts

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, Chief scientist

Study Record Dates

First Submitted

April 2, 2024

First Posted

May 29, 2024

Study Start

May 20, 2024

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations