Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2020-01-01
2021-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dietary Macronutrient Manipulation and Substrate Oxidation During Exercise
NCT02605291
Effects of a Recovery Supplement on Body Composition, Performance, Muscular Properties, and Wellbeing
NCT05769101
Ketone Administration During Inactivity and Retraining
NCT05398042
Acute Effects of Exercise Combined With Ketone Ester Supplement
NCT06365957
Caffeine and Sodium Bicarbonate Supplementation Effects on Resistance Training Performance
NCT06714331
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fat rich diet
Participants consuming 3 days of fat rich diet
investigate the nutritional determinants of MFO in moderate to well-train individuals
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 individuals
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.
Carbohydrate rich diet
Participants consuming 3 days of carbohydrate rich diet
investigate the nutritional determinants of MFO in moderate to well-train individuals
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 individuals
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
investigate the nutritional determinants of MFO in moderate to well-train individuals
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 individuals
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Physical activity \> 3 times/week
* Maximal aerobic capacity \> 50 mlO2/min/kg
* BMI \< 30 kg/m2
Exclusion Criteria
* 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
18 Years
40 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Deakin University
OTHER
University of Copenhagen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jørn Wulff Helge
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jørn Helge, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Variation in MFO
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.