NCT04935983

Brief Summary

It is well known that, even in quite homogenous populations, inter-individual variability in fat oxidation during exercise, in particular MFO, is quite large. Individual factors like gender, body composition (lean mass) and fitness level do explain a substantial part of this variation. In addition, genetic factors do underlie differences between individuals. But also 'external factors' like nutritional status, i.e. a low or high carbohydrate (CHO) availability, and exhaustion are likely linked to maximal fat oxidation, due to alterations in substrate availability. The contribution of these external factors to alterations in substrate utilization is, as of yet, unknown. This study aims to establish the impact of pre-exercise CHO availability and exhaustion on maximal fat oxidation (MFO \& FATmax) during exercise

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 5, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

March 5, 2020

Last Update Submit

June 11, 2021

Conditions

Keywords

exercisefat oxidation

Outcome Measures

Primary Outcomes (2)

  • Maximal fat oxidation during exercise (MFO)

    The main study parameter is maximal fat oxidation during exercise, expressed as MFO (g/min) as assessed during a graded exercise test (35W/ 3min protocol)

    36 hours

  • Relative intensity maximal fat oxidation during exercise ('Fatmax')

    The second study parameter is the relative exercise intensity at which maximal fat oxidation during exercise occurs, expressed as nd FATmax (%) as assessed during a graded exercise test (35W/ 3min protocol)

    36 hours

Study Arms (2)

High CHO

ACTIVE COMPARATOR

High CHO diet for 36 h

Other: High CHO

Low CHO

EXPERIMENTAL

Low CHO diet for 36 h

Other: Low CHO

Interventions

Diet with high carbohydrate content

High CHO
Low CHOOTHER

Diet with low carbohydrate content

Low CHO

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy (self-reported)
  • aged between 20 and 35
  • BMI between 18.5 to 27 kg/m2
  • Recreationally active, defined as minimal of 3 hours training per week, and a maximum of 10 hours a week
  • The sport a participant is engaged in should be a game sport, endurance sport, or should at least contain a major endurance component. Examples of sports that can be included are: distance running, cycling, triathlon, crossfit, and game sports like soccer, rugby, handball, hockey,
  • ○ For part 2 subjects should be used to prolonged cycling exercise
  • Able to be present and participate at all test days and willing and able to follow prescribed interventions

You may not qualify if:

  • Inactive (defined as \<3 hours of training per week)
  • Non-recreational athlete (\>10 hours of training per week)
  • active in a sport without a major endurance component
  • Smokers, defined as someone who has smoked regularly in the previous year.
  • Excessive alcohol consumption (i.e. more than 14 units for males per week; 7 units for females)
  • Drug use
  • The more 'extreme' diets (like veganism, ketogenic diet, raw-food, carnivore diet etc.)
  • Participation in another biomedical study possibly interfering with the study results within 1 month before the first study visit
  • Inability to participate and/or complete the required measurements
  • People working for the department of Human Nutrition and Health (including Master thesis students)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Human Nutrition, Wageningen University

Wageningen, Gelderland, 6703 HA, Netherlands

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2020

First Posted

June 23, 2021

Study Start

September 1, 2020

Primary Completion

December 1, 2021

Study Completion

April 1, 2022

Last Updated

June 23, 2021

Record last verified: 2021-06

Locations