- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665948
Effect of Ketogenic and Carbohydrate Diet in Crossfit
May 14, 2024 updated by: Krzysztof Durkalec-Michalski, Poznan University of Physical Education
The Effect of Ketogenic and Carbohydrate, Low-Glycemic Index Diet on Physical and Specific Performance Capacity, and Exercise Metabolism in Crossfit- Trained Athletes
The purpose of the presented study was to assess the influence of Ketogenic (KD) and a carbohydrate diet with a low glycemic index (CHO-LGI) of a 4-week diet on physical and specific performance capacity, exercise metabolism, as well as concentrations of the selected biochemical blood markers in Crossfit- trained athletes, in a randomised and parallel trial.
Study Overview
Status
Active, not recruiting
Detailed Description
The impact of various dietary strategies, including the alternative ketogenic diet - recently popular among strength athletes, has not been unequivocally assessed in the high-intensity sport disciplines that Crossfit belongs to.
There is also a lack of data in these disciplines about the potential longer adaptation of athletes to the very low carbohydrate intake resulting from the ketogenic diet and its impact in high-intensity Crossfit training.
Therefore, the purpose of this study was the assessment of the influence of a 4-week KD and a CHO-LGI diet on physical and specific performance capacity, exercise metabolism, as well as concentrations of the selected biochemical blood markers in Crossfit- trained athletes, in a randomised and parallel trial.
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Poznań, Poland, 60-624
- Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- written consent to participate,
- a current medical clearance to practice sports,
- training experience: at least 2 years,
- minimum of 4 workout sessions (Crossfit) a week.
Exclusion Criteria:
- current injury,
- any health-related contraindication,
- declared general feeling of being unwell,
- unwilling to follow the study protocol,
- smoking, illicit drug use, alcohol consumption greater than 1-2 drinks/week, dietary supplements use less than 3 weeks before the study,
- females- being pregnant or planning to become pregnant during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ketogenic Diet (KD)
Group consuming very low carbohydrate ketogenic diet.
The ketogenic diet model was energetically normalized (covered the estimated energy expenditure) and assumed coverage of the daily energy requirement up to 5% of energy from carbohydrates.
Proteins were administered in the amount of 1.7 g per kilogram of body mass.
The remaining energy needs were covered with fats (fats covered more than 75% of the daily energy requirement).
Each of the subjects in this group received 10-day menus.
|
The experimental procedure for each randomly assigned participant included a 4-week of KD diet.
|
|
Active Comparator: Low-Glycemic Index Diet (CHO-LGI)
Group consuming carbohydrate, low-glycemic index diet.
The carbohydrate diet model with a low glycemic index was energetically normalized (covered the estimated energy expenditure) and assumed coverage of the daily energy requirement of 25% of fat.
Proteins were administered in the amount of 1.7 g per kilogram of body mass.
The remaining energy needs were covered with carbohydrates (carbohydrates covered about ~55% of the daily energy requirement).
The glycemic index of individual meals as well as the daily diet was calculated in accordance with the appropriate recommendations.
Each of the subjects in this group received 10-day menus.
|
The experimental procedure for each randomly assigned participant included a 4-week of CHO-LGI diet.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in aerobic capacity following dietary intervention
Time Frame: Baseline and after 4 weeks
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Baseline and after 4 weeks
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Changes in CrossFit-specific performance capacity (Fight Gone Bad test) following dietary intervention
Time Frame: Baseline and after 4 weeks
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The number of correctly performed repetitions of exercises (reps)
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Baseline and after 4 weeks
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Changes in energy substrates utilization following dietary intervention
Time Frame: Baseline and after 4 weeks
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Fats (g/min) and carbohydrates (g/min) oxidation analysis
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Baseline and after 4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in fat mass and fat free mass following dietary intervention
Time Frame: Baseline and after 4 weeks
|
Fat mass (kg) and fat free mass (kg) analysis
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Baseline and after 4 weeks
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Changes of red and white blood cell concentration in blood following dietary intervention
Time Frame: Baseline and after 4 weeks
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Red blood cells (RBC) [mln/mm³] and white blood cells (WBC) [mln/mm³] concentration analysis
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Baseline and after 4 weeks
|
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Changes in blood glucose and hemoglobin concentration following dietary intervention
Time Frame: Baseline and after 4 weeks
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Hemoglobin (Hb) [g/dl] and glucose [g/dl] concentration analysis
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Baseline and after 4 weeks
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Changes in blood hematocrit levels following dietary intervention
Time Frame: Baseline and after 4 weeks
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Hematocrit (HCT) [%] level analysis
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Baseline and after 4 weeks
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Changes of testosterone, cortisol, urea, lactate and pyruvate concentration in blood following dietary intervention
Time Frame: Baseline and after 4 weeks
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Testosterone [mmol/L], cortisol [mmol/L], urea [mmol/L], lactate [mmol/L] and pyruvate [mmol/L] concentration analysis
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Baseline and after 4 weeks
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Changes of creatine kinase, lactate dehydrogenase, alanine aminotransferase and aspartate aminotransferase activity in blood after following dietary intervention
Time Frame: Baseline and after 4 weeks
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Creatine kinase [U/L], lactate dehydrogenase [U/L], alanine aminotransferase [U/L] and aspartate aminotransferase [U/L] activity analysis
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Baseline and after 4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jan Jeszka, Professor, Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2017
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 20, 2024
Study Registration Dates
First Submitted
September 5, 2018
First Submitted That Met QC Criteria
September 7, 2018
First Posted (Actual)
September 11, 2018
Study Record Updates
Last Update Posted (Actual)
May 16, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ULS00004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Shared data will be exclusively related to the level recorded indicators (anaerobic capacity and specific performance capacity indicators, exercise metabolism, levels of biochemical markers, and body composition), without personal data.
The data obtained will be attached to scientific publications, depending on the requirements of the journal.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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