Sources and Mechanisms of Energy Compensation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-40
SponsorShenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults (men)
18-40 years old
BMI (body mass index)≥18.5 kg/m2
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Power Bike（Ergoselect 100P）
Other interventionChanges 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.
Treatment groups
81 Participants
are divided into 1 treatment groupGroup A: Moderate to high intensity exerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Macronutrient preference
Macronutrients preference will be recorded by the feeding table, macronutrient preference will be calculated in percentage(%).
Time frame
During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.2
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).
Time frame
During lunchtime and dinnertime on both the control day(baseline) and exercise day(the day after control day), each test lasting for 40 minutes.3
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.
Time frame
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
1
Blood glucose
Blood glucose will be recorded by the continuous glucose monitoring system(CGM) in mmol/L.
Time frame
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.2
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 12 hours. For a valid measure the goal is to get 2 weekday and 2 weekend days.
Time frame
Wear it for 14 days from the physical examination day3
Ambient temperature
The iButton (DS1921G) monitors will be provided for the assessment of both indoor and outdoor temperature of their living environment in centigrade(℃). The iButtons can be affixed to the hand bag (or clothes) to measure the subject exposure temperature, an indoor wall of home and workplace, and the building outside to measure the outdoor temperature using a strip of adhesive, water resistant, medical grade tape.
Time frame
Wear it for 14 days from the physical examination day4
Circulating Biochemical indexes and hormones
Levels of circulating hormones (including leptin, insulin, ghrelin etc) will be measured when fasted and after a standard intervention meal. Levels of circulating hormones in the serum will be measured by ELISA (Bio Tek, Synergy4) in mmol/L.
Time frame
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)Sponsors and contacts
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Source ClinicalTrials.gov