NCT03665948

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 9, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

7.8 years

First QC Date

September 5, 2018

Last Update Submit

May 14, 2024

Conditions

Keywords

Sports NutritionKetogenic DietLow Glycemic Index DietCrossfitPhysical capacityPerformanceExercise metabolismTraining support

Outcome Measures

Primary Outcomes (3)

  • Changes in aerobic capacity following dietary intervention

    Baseline and after 4 weeks

  • Changes in CrossFit-specific performance capacity (Fight Gone Bad test) following dietary intervention

    The number of correctly performed repetitions of exercises (reps)

    Baseline and after 4 weeks

  • Changes in energy substrates utilization following dietary intervention

    Fats (g/min) and carbohydrates (g/min) oxidation analysis

    Baseline and after 4 weeks

Secondary Outcomes (6)

  • Changes in fat mass and fat free mass following dietary intervention

    Baseline and after 4 weeks

  • Changes of red and white blood cell concentration in blood following dietary intervention

    Baseline and after 4 weeks

  • Changes in blood glucose and hemoglobin concentration following dietary intervention

    Baseline and after 4 weeks

  • Changes in blood hematocrit levels following dietary intervention

    Baseline and after 4 weeks

  • Changes of testosterone, cortisol, urea, lactate and pyruvate concentration in blood following dietary intervention

    Baseline and after 4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Ketogenic Diet (KD)

EXPERIMENTAL

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.

Other: Dietary Intervention - Ketogenic Diet (KD)

Low-Glycemic Index Diet (CHO-LGI)

ACTIVE COMPARATOR

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.

Other: Dietary Intervention - Low-Glycemic Index Diet (CHO-LGI)

Interventions

The experimental procedure for each randomly assigned participant included a 4-week of KD diet.

Ketogenic Diet (KD)

The experimental procedure for each randomly assigned participant included a 4-week of CHO-LGI diet.

Low-Glycemic Index Diet (CHO-LGI)

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences

Poznan, 60-624, Poland

Location

Related Publications (1)

  • Durkalec-Michalski K, Nowaczyk PM, Siedzik K. Effect of a four-week ketogenic diet on exercise metabolism in CrossFit-trained athletes. J Int Soc Sports Nutr. 2019 Apr 5;16(1):16. doi: 10.1186/s12970-019-0284-9.

Study Officials

  • Jan Jeszka, Professor

    Institute of Human Nutrition and Dietetics, Poznan University of Life Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 11, 2018

Study Start

January 9, 2017

Primary Completion

November 1, 2024

Study Completion

December 20, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations