NCT04678713

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

November 13, 2020

Last Update Submit

February 14, 2024

Conditions

Keywords

Maximal fat oxidationKetogenic dietCarbohydrate rich dietFat rich dietMaximal aerobic capacityTrained individualsAdipose triglyceride lipaseThe maximal fat oxidation intensityGlucose Transporter 4Citrate synthaseHydroxyacyl-Coenzyme A dehydrogenaseHormone sensitive lipaseIntramuscular TriacylglycerolRespiratory exchanges ratioGlycogen synthaseHexokinase II

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and after three days diet

Secondary Outcomes (1)

  • Change in muscle triacylglycerol

    Baseline and after three days diet

Study Arms (2)

Fat rich diet

EXPERIMENTAL

Participants consuming 3 days of fat rich diet

Dietary Supplement: investigate the nutritional determinants of MFO in moderate to well-train individualsOther: Investigate the physiological determinants of MFO in moderate to well-train individuals

Carbohydrate rich diet

EXPERIMENTAL

Participants consuming 3 days of carbohydrate rich diet

Dietary Supplement: investigate the nutritional determinants of MFO in moderate to well-train individualsOther: Investigate the physiological determinants of MFO in moderate to well-train individuals

Interventions

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.

Carbohydrate rich dietFat rich diet

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 dietFat rich diet

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18 to 40 years
  • Physical activity \> 3 times/week
  • Maximal aerobic capacity \> 50 mlO2/min/kg
  • BMI \< 30 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xlab, Faculty of Health and Medical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

ObesityWolman Disease

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCholesterol Ester Storage DiseaseLipidosesLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesInfant, Newborn, DiseasesLipid Metabolism DisordersMetabolic Diseases

Study Officials

  • Jørn Helge, Professor

    Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
As the participants receive a specific diet, and have to buy their gloceries themself, it is not possible to mask what kind of diet they consume. They will be randomised into what kind of diet they receive.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2020

First Posted

December 22, 2020

Study Start

January 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 30, 2021

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations