HealthyFATOXNCT03864679
Investigation of Fat Oxidation During Moderate Versus Vigorous Intensity Exercise
A study testing Exercise in people with Healthy and Sedentary Lifestyle, run by Latvian Institute of Organic Synthesis at 1 site in Latvia.
Trial summary
Exercise is widely suggested as an important lifestyle change for weight loss, however, the optimal level of intensity moderate versus vigorous remains unclear. It is known that in athletes, during very high-intensity exercise, fat oxidation is decreased and energy is gained mainly from carbohydrate utilization. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Sedentary Lifestyle
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteLatvia
- Study dates
- 18 Jun 2018to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Fat and Carbohydrate Oxidation During Moderate Versus Vigorous Intensity Exercise in Healthy Volunteers With Sedentary Lifestyle
Exercise is widely suggested as an important lifestyle change for weight loss, however, the optimal level of intensity moderate versus vigorous remains unclear. It is known that in athletes, during very high-intensity exercise, fat oxidation is decreased and energy is gained mainly from carbohydrate utilization. The aim of this study is to find an optimal workload based on fat oxidation rate during exercise in volunteers with a sedentary lifestyle.
Read the 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.
- Conditions
- Healthy, Sedentary Lifestyle
- Being tested
- Exercise
- Keywords
- exercise, fed, fasted, fat, carbohydrate
- Medical subject headings
- Sedentary Behavior, Motor Activity, Lecithin Cholesterol Acyltransferase Deficiency, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Subjects will perform a cycling tests Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal workload
The exercise workload (W) for optimal fat burning during exercise
Measured: 30 min accelerated load cycling exercise
Heart rate change
Change in heart rate (BPM) from rest to the optimal workload
Measured: 30 min accelerated load cycling exercise and 60 min optimal intensity cycling exercise
Secondary outcomes (1)
Influence of fed and fasted state
The influence of fed and fasted state on maximal whole body fat oxidation rate during exercise
Measured: 30 min accelerated load cycling exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start18 Jun 2018
- Primary completion15 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latvian Institute of Organic Synthesis
- Sponsor type
- University, hospital or other
- Collaborators
- Riga East University Hospital, University of Latvia, Riga Stradins University
- Responsible party
- Sponsor
- Investigators
- Ilze Konrade, Principal investigator, Riga East University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03864679
- Sponsor's protocol ID
- Exercise 2018-1
- Acronym
- FATOX
- Status last verified
- Mar 2019
- First submitted
- 22 Jun 2018
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Fat and Carbohydrate Oxidation During Moderate Versus Vigorous Intensity Exercise in Healthy Volunteers With Sedentary Lifestyle
- ClinicalTrials.gov ID
- NCT03864679
- Acronym / sponsor ID
- FATOX / Exercise 2018-1
- Conditions
- Healthy, Sedentary Lifestyle
- Keywords
- exercise, fed, fasted, fat, carbohydrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Latvian Institute of Organic SynthesisUniversity, hospital or other
- Collaborators
- Riga East University Hospital, University of Latvia, Riga Stradins University
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise is widely suggested as an important lifestyle change for weight loss, however, the optimal level of intensity moderate versus vigorous remains unclear. It is known that in athletes, during very high-intensity exercise, fat oxidation is decreased and energy is gained mainly from carbohydrate utilization. The aim of this study is to find an optimal workload based on fat oxidation rate during exercise in volunteers with a sedentary lifestyle.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseSubjects will perform a cycling tests |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseSubjects 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). | Other | Exercise |
Primary outcome
Optimal workload
Time frame: 30 min accelerated load cycling exercise
The exercise workload (W) for optimal fat burning during 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
1 secondary outcome
Influence of fed and fasted state
Time frame: 30 min accelerated load cycling exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilze Konrade principal investigator
Riga East University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy and Sedentary Lifestyle, run by Latvian Institute of Organic Synthesis at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal workload (time frame: 30 min accelerated load cycling exercise). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.