ObesityNCT04678713
Maximal Fat Oxidation and Fuel Use During Exercise
A study testing investigate the nutritional determinants of MFO in moderate to well-train individuals and Investigate the physiological determinants of MFO in moderate to well-train individuals in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Fat and carbohydrate are the two main energy stores available as fuel during exercise. It is well known that the exercise intensity and feeding status are the major factors determining the type of fuel used during exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- investigate the nutritional determinants of MFO in moderate to well-train individuals and Investigate the physiological determinants of MFO in moderate to well-train individuals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2020to 30 Sep 2021
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 40 years
- Physical activity > 3 times/week
- Maximal aerobic capacity > 50 mlO2/min/kg
- BMI < 30 kg/m2
Who cannot join
- Aged below 18 years or above 40 years
- Maximal aerobic capacity < 50 mlO2/kg/min
- Body mass index > 30 kg/m2
- Taking any prescription medication influencing metabolism
- Having existing cardiovascular, metabolic or musculoskeletal conditions that may influence ability to exercise or study outcomes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Copenhagen, 2200
About this study
Fat and carbohydrate are the two main energy stores available as fuel during exercise. It is well known that the exercise intensity and feeding status are the major factors determining the type of fuel used during exercise. During prolonged exercise at low to moderate exercise fat is the primary fuel being used and to improve performance studies has tried to understand strategies to maximize muscle glycogen storage and elevate fat oxidation during exercise. With this strategy they aim for preserving the limited muscle glycogen stores and thus improving endurance performance. In relation to this the maximal fat oxidation (MFO: The highest rate of fat oxidation across all exercise intensities) has been studied as increasing the fat oxidation could decrease the depletion of the glycogen stores. Further it has recently been shown that MFO is related to performance in endurance trained. However the MFO has been found to vary markedly between trained individuals matched on their activity level.
It has been suggested that the diet and subsequent substrate availability during exercise contributes independently to the variation in MFO. However, the measurements have never been evaluated in a trained group with similar aerobic capacity and training status. Therefore, the aim of the study is to investigate the effect of a short term fat rich or carbohydrate rich diet on MFO in well trained men with a high vs. a low MFO. The hypothesis is that 3 days of a fat-rich diet will increase MFO while 3 days of a Carbohydrate rich diet will decrease MFO in both individuals with a high MFO (HiMFO) and a low MFO (LoMFO). Furthermore, it is hypothesized that HiMFO will have a significantly higher MFO after both diets compared to LoMFO.
Lifestyle and physiological factors have been investigated to determine the variation of the MFO capacity. However, these factors can only explain 50% of the interindividual variability in MFO. Despite the critical role of fat oxidation during exercise, few studies have explored the differences in skeletal muscle characteristics between HiMFO and LoMFO. The second aim of the study is thereby to investigate if muscle characteristics can explain the variability in MFO within well-trained males. The hypothesis is that HiMFO will have more favorable muscle characteristics for fat oxidation compared to LoMFO including a higher oxidative capacity, intramuscular triacylglycerol concentration and a higher expression of key enzymes in lipid metabolism.
Read the detailed description
A group of young, healthy and moderate to well-trained males will be recruited for the study. The participants will be separated into 2 groups by stratified randomization consuming either a 3 day Fat rich diet (HiFAT) or a carbohydrate rich diet (HiCHO).
When all participants have completed the study, the results will be analysed by separating the two groups into two subgroups based on the median of the MFO
The study includes 4 visits to out laboratory.
When the participants have read, accepted and signed the plain language statement they will be invited for a screening session in our laboratory which is the first visit. If the participant meet the inclusion and not the exclusion criteria, they will be included in the study and a time schedule for the next three visits will be planned. In the end of the screening the participant will be instructed to full fill a 4-day diet dairy to analyse the participants habitual diet.
For the second visit the participant will meet in the laboratory after an overnight fast and has been asked to avoid alcohol and strenuous exercise 48 hours prior to the test day. The second test starts with a visit to the toilet before a Dual-energy X-ray absorptiometry (DXA) scan and a bioelectrical impedance scan (BIA) is performed to measure the body composition of the participant. After 5 min. of rest, the blood pressure is measured followed by a measurement of the hip and waist circumference. After measuring the blood pressure and body composition the participant will perform a incremental exercise test on a cycle ergometer. The expired air is measured by indirect calorimetry and is used to calculate the maximal fat oxidation and maximal aerobic capacity.
As the second visit, the participant will arrive to laboratory in the morning after an overnight fast having been asked to avoid alcohol and strenuous exercise 48 hours prior to the test day. At the third visit a resting blood samples, fat and muscle biopsies are collected. After 30 min. of rest the same incremental exercise test will be performed as at visit 2 to measure the maximal fat oxidation and maximal aerobic capacity. The test is performed twice to minimize the variation and to ensure the circumstances with the biopsies are identical before and after the diet intervention.
At the end of the third visit, the participant will receive a high fat or isoenergetic high carbohydrate diet to follow for the next three days. The participant will further receive an activity watch to track his activity level during the diet intervention and he will be instructed to exercise for one hour at 65 % of his maximal heart rate.
The fourth and last visit to the laboratory is the day after finishing the three days diet intervention. The participant arrive to laboratory in the morning after an overnight fast having been asked to avoid alcohol and strenuous exercise 48 hours prior to the test day. The test day initiates with a visit to the toilet to empty the bladder and a DXA and BIA are performed followed by a measurement of the blood pressure and the hip and waist circumference. The participant is led to the laboratory where he has to rest for 5-10 min. before collecting a resting blood sample and a fat and muscle biopsy. The participant has to rest for further 30 min. before performing the incremental exercise test to measure the maximal fat oxidation and maximal aerobic capacity.
Procedure and analysis:
Blood samples: The blood samples will be collected from the vein cubiti medialis in the forearm. The blood samples will be analyzed using a standard lab biochemical assays to assess metabolic risk factors and plasma metabolites and hormones.
Fat biopsy: The fat biopsies will be collected from the abdominal subcutane adipose tissue 3-5 cm. lateral from the navel. The samples will be collected by the Bergstrom biopsy technique using a Bergstrom biopsy needle. The fat biopsy will be analysed using microscopy and High Resolution Mitochondria Respirometry to assess the mitochondria capacity, the inflammation of the macrophage and the size of the adipose cells. Furthermore, the expression of proteins and enzymes important for the glucose and fat metabolism will be measured.
Muscle biopsy: The muscle biopsies will be collected from musculus vastus lateralis by the doctor of our department using the Bergstrom biopsy technique. The muscle biopsy will be analysed by immunofluorescence microscopy and the Western blot technique to assess muscle characteristics (e.g muscle fibre type, capillary density and fibre type specific IMTG content) and the expression of key proteins involved in FFA uptake, intramuscular lipolysis and fat oxidation.
The expected outcomes This study will help us to understand the underlying muscular mechanism explaining why substrate use is different amongst a group of similar well-trained athletes. The study will further illuminate if individuals with a high maximal fat oxidation react differently to a high fat or carbohydrate diet compared to individuals with a low maximal fat oxidation.
This information will be highly relevant for coaches, federations, nutritionists and endurance trained athletes looking to optimize nutritional and training methods to enhance metabolic responses and ultimately improve exercise performance.
Statistical analysis:
A Pearsons correlation analyse was performed including all relevant physiological variables regarding the primary outcome, Maximal fat oxidation to analyse the physiological differences between the group with a high MFO and low MFO.
Furthermore a two way ANOVA with repeated measurements will be performed to analyse any effect of the diet on MFO and to analyse if there is any differences on the effect of diet between individuals with a high compared to low MFO. Any significant effects from the ANOVA test will be analysed with a post hoc test to evaluate the interaction between HiMFO and LoMFO.
The significant level is p<0.05.
General design:
The project was approved by the Science Ethical commitee of the greater region of Copenhagen (H-20019103) the 3rd of July 2020. The protocol of the study adhered to the principles of the Helsinki declaration.
- Conditions
- Obesity
- Being tested
- investigate the nutritional determinants of MFO in moderate to well-train individuals, Investigate the physiological determinants of MFO in moderate to well-train individuals
- Keywords
- Maximal fat oxidation, Ketogenic diet, Carbohydrate rich diet, Fat rich diet, Maximal aerobic capacity, Trained individuals, Adipose triglyceride lipase, The maximal fat oxidation intensity, Glucose Transporter 4, Citrate synthase, Hydroxyacyl-Coenzyme A dehydrogenase, Hormone sensitive lipase, Intramuscular Triacylglycerol, Respiratory exchanges ratio, Glycogen synthase, Hexokinase II
- Medical subject headings
- Obesity, Wolman Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigate the nutritional determinants of MFO in moderate to well-train individualsDietary supplement
The participants will receive a 3-day fat rich or a carbohydrate rich diet. The participants will perform a maximal fat oxidation test before and after the diet intervention to evaluate the effect of the two diets on MFO.
Investigate the physiological determinants of MFO in moderate to well-train individualsOther
Muscle biopsies will be obtained at baseline to compare muscle characteristics between well-matched train individuals with a high compared to a low maximal fat oxidation.
| Study group | Role | What they receive |
|---|---|---|
| Fat rich diet | Experimental | Participants consuming 3 days of fat rich diet Receives: Dietary Supplement: investigate the nutritional determinants of MFO in moderate to well-train individuals; Other: Investigate the physiological determinants of MFO in moderate to well-train individuals |
| Carbohydrate rich diet | Experimental | Participants consuming 3 days of carbohydrate rich diet Receives: Dietary Supplement: investigate the nutritional determinants of MFO in moderate to well-train individuals; Other: Investigate the physiological determinants of MFO in moderate to well-train individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximal fat oxidation
Change in maximal fat oxidation (gram/min.) from baseline to after 3-day carbohydrate rich or fat rich diet in moderately trained males
Measured: Baseline and after three days diet
Secondary outcomes (1)
Change in muscle triacylglycerol
Change in muscle triacylglycerol (arbitrary unit) from baseline to after 3-day carbohydrate rich vs. fat rich diet in moderately trained males
Measured: Baseline and after three days diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Jan 2020
- Primary completion1 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be separated into 2 groups by stratified randomization consuming either a Fat rich diet (HiFAT) or a carbohydrate rich diet (HiCHO) (n=40 in total). When all 40 participants have completed the study, the results will be analysed by separating the two groups into two subgroups based on the median of the MFO
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Deakin University
- Responsible party
- Principal investigator, Jørn Wulff Helge, University of Copenhagen
- Investigators
- Jørn Helge, Professor, Principal investigator, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678713
- Sponsor's protocol ID
- Variation in MFO
- Status last verified
- Feb 2024
- First submitted
- 13 Nov 2020
- Last updated
- 15 Feb 2024
- 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 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Fat Oxidation and Fuel Use During Exercise
- ClinicalTrials.gov ID
- NCT04678713
- Acronym / sponsor ID
- Variation in MFO
- Conditions
- Obesity
- Keywords
- Maximal fat oxidation, Ketogenic diet, Carbohydrate rich diet, Fat rich diet, Maximal aerobic capacity, Trained individuals, Adipose triglyceride lipase, The maximal fat oxidation intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Deakin University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 22 Dec 2020 (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.
Fat and carbohydrate are the two main energy stores available as fuel during exercise. It is well known that the exercise intensity and feeding status are the major factors determining the type of fuel used during exercise. During prolonged exercise at low to moderate exercise fat is the primary fuel being used and to improve performance studies has tried to understand strategies to maximize muscle glycogen storage and elevate fat oxidation during exercise. With this strategy they aim for preserving the limited muscle glycogen stores and thus improving endurance performance. In relation to this the maximal fat oxidation (MFO: The highest rate of fat oxidation across all exercise intensities) has been studied as increasing the fat oxidation could decrease the depletion of the glycogen stores. Further it has recently been shown that MFO is related to performance in endurance trained. However the MFO has been found to vary markedly between trained individuals matched on their activity level.
It has been suggested that the diet and subsequent substrate availability during exercise contributes independently to the variation in MFO. However, the measurements have never been evaluated in a trained group with similar aerobic capacity and training status. Therefore, the aim of the study is to investigate the effect of a short term fat rich or carbohydrate rich diet on MFO in well trained men with a high vs. a low MFO. The hypothesis is that 3 days of a fat-rich diet will increase MFO while 3 days of a Carbohydrate rich diet will decrease MFO in both individuals with a high MFO (HiMFO) and a low MFO (LoMFO). Furthermore, it is hypothesized that HiMFO will have a significantly higher MFO after both diets compared to LoMFO.
Lifestyle and physiological factors have been investigated to determine the variation of the MFO capacity. However, these factors can only explain 50% of the interindividual variability in MFO. Despite the critical role of fat oxidation during exercise, few studies have explored the differences in skeletal muscle characteristics between HiMFO and LoMFO. The second aim of the study is thereby to investigate if muscle characteristics can explain the variability in MFO within well-trained males. The hypothesis is that HiMFO will have more favorable muscle characteristics for fat oxidation compared to LoMFO including a higher oxidative capacity, intramuscular triacylglycerol concentration and a higher expression of key enzymes in lipid metabolism.
Detailed description
A group of young, healthy and moderate to well-trained males will be recruited for the study. The participants will be separated into 2 groups by stratified randomization consuming either a 3 day Fat rich diet (HiFAT) or a carbohydrate rich diet (HiCHO).
When all participants have completed the study, the results will be analysed by separating the two groups into two subgroups based on the median of the MFO
The study includes 4 visits to out laboratory.
When the participants have read, accepted and signed the plain language statement they will be invited for a screening session in our laboratory which is the first visit. If the participant meet the inclusion and not the exclusion criteria, they will be included in the study and a time schedule for the next three visits will be planned. In the end of the screening the participant will be instructed to full fill a 4-day diet dairy to analyse the participants habitual diet.
For the second visit the participant will meet in the laboratory after an overnight fast and has been asked to avoid alcohol and strenuous exercise 48 hours prior to the test day. The second test starts with a visit to the toilet before a Dual-energy X-ray absorptiometry (DXA) scan and a bioelectrical impedance scan (BIA) is performed to measure the body composition of the participant. After 5 min. of rest, the blood pressure is measured followed by a measurement of the hip and waist circumference. After measuring the blood pressure and body composition the participant will perform a incremental exercise test on a cycle ergometer. The expired air is measured by indirect calorimetry and is used to calculate the maximal fat oxidation and maximal aerobic capacity.
As the second visit, the participant will arrive to laboratory in the morning after an overnight fast having been asked to avoid alcohol and strenuous exercise 48 hours prior to the test day. At the third visit a resting blood samples, fat and muscle biopsies are collected. After 30 min. of rest the same incremental exercise test will be performed as at visit 2 to measure the maximal fat oxidation and maximal aerobic capacity. The test is performed twice to minimize the variation and to ensure the circumstances with the biopsies are identical before and after the diet intervention.
At the end of the third visit, the participant will receive a high fat or isoenergetic high carbohydrate diet to follow for the next three days. The participant will further receive an activity watch to track his activity level during the diet intervention and he will be instructed to exercise for one hour at 65 % of his maximal heart rate.
The fourth and last visit to the laboratory is the day after finishing the three days diet intervention. The participant arrive to laboratory in the morning after an overnight fast having been asked to avoid alcohol and strenuous exercise 48 hours prior to the test day. The test day initiates with a visit to the toilet to empty the bladder and a DXA and BIA are performed followed by a measurement of the blood pressure and the hip and waist circumference. The participant is led to the laboratory where he has to rest for 5-10 min. before collecting a resting blood sample and a fat and muscle biopsy. The participant has to rest for further 30 min. before performing the incremental exercise test to measure the maximal fat oxidation and maximal aerobic capacity.
Procedure and analysis:
Blood samples: The blood samples will be collected from the vein cubiti medialis in the forearm. The blood samples will be analyzed using a standard lab biochemical assays to assess metabolic risk factors and plasma metabolites and hormones.
Fat biopsy: The fat biopsies will be collected from the abdominal subcutane adipose tissue 3-5 cm. lateral from the navel. The samples will be collected by the Bergstrom biopsy technique using a Bergstrom biopsy needle. The fat biopsy will be analysed using microscopy and High Resolution Mitochondria Respirometry to assess the mitochondria capacity, the inflammation of the macrophage and the size of the adipose cells. Furthermore, the expression of proteins and enzymes important for the glucose and fat metabolism will be measured.
Muscle biopsy: The muscle biopsies will be collected from musculus vastus lateralis by the doctor of our department using the Bergstrom biopsy technique. The muscle biopsy will be analysed by immunofluorescence microscopy and the Western blot technique to assess muscle characteristics (e.g muscle fibre type, capillary density and fibre type specific IMTG content) and the expression of key proteins involved in FFA uptake, intramuscular lipolysis and fat oxidation.
The expected outcomes This study will help us to understand the underlying muscular mechanism explaining why substrate use is different amongst a group of similar well-trained athletes. The study will further illuminate if individuals with a high maximal fat oxidation react differently to a high fat or carbohydrate diet compared to individuals with a low maximal fat oxidation.
This information will be highly relevant for coaches, federations, nutritionists and endurance trained athletes looking to optimize nutritional and training methods to enhance metabolic responses and ultimately improve exercise performance.
Statistical analysis:
A Pearsons correlation analyse was performed including all relevant physiological variables regarding the primary outcome, Maximal fat oxidation to analyse the physiological differences between the group with a high MFO and low MFO.
Furthermore a two way ANOVA with repeated measurements will be performed to analyse any effect of the diet on MFO and to analyse if there is any differences on the effect of diet between individuals with a high compared to low MFO. Any significant effects from the ANOVA test will be analysed with a post hoc test to evaluate the interaction between HiMFO and LoMFO.
The significant level is p<0.05.
General design:
The project was approved by the Science Ethical commitee of the greater region of Copenhagen (H-20019103) the 3rd of July 2020. The protocol of the study adhered to the principles of the Helsinki declaration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be separated into 2 groups by stratified randomization consuming either a Fat rich diet (HiFAT) or a carbohydrate rich diet (HiCHO) (n=40 in total). When all 40 participants have completed the study, the results will be analysed by separating the two groups into two subgroups based on the median of the MFO
| Arm | Type | Receives |
|---|---|---|
| Fat rich diet | Experimental | Dietary Supplement: investigate the nutritional determinants of MFO in moderate to well-train individuals, Other: Investigate the physiological determinants of MFO in moderate to well-train individualsParticipants consuming 3 days of fat rich diet |
| Carbohydrate rich diet | Experimental | Dietary Supplement: investigate the nutritional determinants of MFO in moderate to well-train individuals, Other: Investigate the physiological determinants of MFO in moderate to well-train individualsParticipants consuming 3 days of carbohydrate rich diet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18 to 40 years
- Physical activity > 3 times/week
- Maximal aerobic capacity > 50 mlO2/min/kg
- BMI < 30 kg/m2
Key exclusion criteria (5 listed)
- Aged below 18 years or above 40 years
- Maximal aerobic capacity < 50 mlO2/kg/min
- Body mass index > 30 kg/m2
- Taking any prescription medication influencing metabolism
- Having existing cardiovascular, metabolic or musculoskeletal conditions that may influence ability to exercise or study outcomes
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 |
|---|---|---|
| investigate the nutritional determinants of MFO in moderate to well-train individualsThe participants will receive a 3-day fat rich or a carbohydrate rich diet. The participants will perform a maximal fat oxidation test before and after the diet intervention to evaluate the effect of the two diets on MFO. | Dietary supplement | Carbohydrate rich diet, Fat rich diet |
| Investigate the physiological determinants of MFO in moderate to well-train individualsMuscle biopsies will be obtained at baseline to compare muscle characteristics between well-matched train individuals with a high compared to a low maximal fat oxidation. | Other | Carbohydrate rich diet, Fat rich diet |
Primary outcome
Change in maximal fat oxidation
Time frame: Baseline and after three days diet
Change in maximal fat oxidation (gram/min.) from baseline to after 3-day carbohydrate rich or fat rich diet in moderately trained males
1 secondary outcome
Change in muscle triacylglycerol
Time frame: Baseline and after three days diet
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 15 Feb 2024.
- 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.
Jørn Helge, Professor principal investigator
Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing investigate the nutritional determinants of MFO in moderate to well-train individuals and Investigate the physiological determinants of MFO in moderate to well-train individuals in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
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 4 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 15 Feb 2024. 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 Denmark. 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?
Change in maximal fat oxidation (time frame: Baseline and after three days diet). 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 15 Feb 2024.