- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03864679
Investigation of Fat Oxidation During Moderate Versus Vigorous Intensity Exercise (FATOX)
Investigation of Fat and Carbohydrate Oxidation During Moderate Versus Vigorous Intensity Exercise in Healthy Volunteers With Sedentary Lifestyle
Study Overview
Detailed Description
It is planned to recruit 12 healthy volunteers with a sedentary lifestyle in the study group. Since different regimens (fed, fasted and moderate versus vigorous) will be compared in the same subjects, no control group is necessary. Subjects will perform a cycling test with 5 min incremental intensity exercise and 1 h cycling test exercising at a moderate-intensity (load will be selected after the incremental intensity exercise). The expiration of carbon dioxide (CO2) and consumption of oxygen (O2) will be measured, to determine the total fatty acid and carbohydrate oxidation during cycling. Concomitantly, it is planned to measure blood lactate and glucose concentrations during exercise experiments as well as a wide range of blood biochemistry parameters before and after exercise.
The investigators expect to find optimal conditions for the sedentary population for burning of fat, which is the major source of energy during moderate-intensity exercise. Measurements of the fat and carbohydrate oxidation in healthy volunteers with a sedentary lifestyle will contribute to the understanding of exercise regimens for the most effective fat oxidation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Riga, Latvia, LV-1004
- Latvian University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy
- Sedentary lifestyle
- BMI 20 - 30 kg/m2
- Be able to attend the laboratory and willing to participate in necessary protocols
- Be willing to undertake the duration of the exercise protocol (3 x 1 hour)
- Have the capacity and willingness to provide informed consent (oral and written)
Exclusion Criteria:
- athletes
- Individuals with chronic cardiovascular disease such as hypertension, valve disease, coronary artery disease, cardiac conduction abnormalities, etc.
- History of pneumothorax or chronic lung disease such as asthma, COPD, bronchiectasis
- Active Smokers
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
Subjects will perform a cycling tests
|
Subjects will perform a cycling test with 5 min incremental intensity exercise and 1 h cycling test exercising at a moderate-intensity (load will be selected in incremental intensity exercise).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Optimal workload
Time Frame: 30 min accelerated load cycling exercise
|
The exercise workload (W) for optimal fat burning during exercise
|
30 min accelerated load cycling exercise
|
Heart rate change
Time Frame: 30 min accelerated load cycling exercise and 60 min optimal intensity cycling exercise
|
Change in heart rate (BPM) from rest to the optimal workload
|
30 min accelerated load cycling exercise and 60 min optimal intensity cycling exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Influence of fed and fasted state
Time Frame: 30 min accelerated load cycling exercise
|
The influence of fed and fasted state on maximal whole body fat oxidation rate during exercise
|
30 min accelerated load cycling exercise
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ilze Konrade, Riga East University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Exercise 2018-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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