- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03062527
Effect of Glycemic Index on Physical Capacity in Runners
Effects of Low and Versus Moderate Glycemic Index Diets on Physical Capacity and Body Composition in Endurance- Trained Runners
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wielkopolska
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Poznan, Wielkopolska, Poland, 60-624
- Poznan University of Life Sciences, ul.Wojska Polskiego 31
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- written consent to participate,
- male and female,
- a current medical clearance to practice sports,
- training experience: at least 3 years,
- minimum of 4 workout sessions a week lasting at least 1.5-2 hours/day,
- age: 17 - 37 years.
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Low Glycemic Index Diet
Group consuming low glycemic index diet. Calculated glycemic index of daily diet was lower than 40. Carbohydrate- containing foods included whole rye bread, pumpernickel bread, whole oats, wheat brans, brown rice, buckwheat, vegetables (besides corn, cooked carrots, potatoes and pumpkin) and fruit such as apples, pears, grapefruits, tangerines, prunes, dried apricots and unripe bananas. Interventions: The experimental procedure for each participant included a 3-week low glycemic index diet. Between the 3-week low and moderate glycemic index diets or a moderate and low glycemic index treatment, a 14-day washout period was introduced. |
|
Experimental: Moderate Glycemic Index Diet
Group consuming moderate glycemic index diet. Calculated glycemic index of diet was higher than 60. Carbohydrate- containing foods included wheat bread, wheat rolls, potatoes, instant oats, cornflakes, white rice, millet, boiled carrots and fruit (ripe bananas, grapes, raisins, dates, cranberry, honey and high sugar jams) Interventions: The experimental procedure for each participant included a 3-week moderate glycemic index diet. Between the 3-week low and moderate glycemic index diets or a moderate and low glycemic index treatment, a 14-day washout period was introduced. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in aerobic capacity following low glycemic index diet
Time Frame: Baseline and after 3 weeks
|
Baseline and after 3 weeks
|
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Changes in aerobic capacity following moderate glycemic index diet
Time Frame: Baseline and after 3 weeks
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Baseline and after 3 weeks
|
|
Changes in performance in 12-min running test following low glycemic index diet
Time Frame: Baseline and after 3 weeks
|
Baseline and after 3 weeks
|
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Changes in performance in 12-min running test following moderate glycemic index diet
Time Frame: Baseline and after 3 weeks
|
Baseline and after 3 weeks
|
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Changes in fat mass and fat free mass following low glycemic index diet
Time Frame: Baseline and after 3 weeks
|
Fat mass (kg) and fat free mass (kg) analysis
|
Baseline and after 3 weeks
|
Changes in fat mass and fat free mass following moderate glycemic index diet
Time Frame: Baseline and after 3 weeks
|
Fat mass (kg) and fat free mass (kg) analysis
|
Baseline and after 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
Time Frame: 1 year
|
1 year
|
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Statistical evaluation of the significance of differences between the changes in performance in 12-min running test
Time Frame: 1 year
|
1 year
|
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Statistical evaluation of the significance of differences between the changes in fat mass and fat free mass
Time Frame: 1 year
|
Fat mass (kg) and fat free mass (kg)
|
1 year
|
Collaborators and Investigators
Investigators
- Study Chair: Jan Jeszka, Professor, Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ULS00001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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