NutritionNCT03062527
Effect of Glycemic Index on Physical Capacity in Runners
A study testing Dietary Intervention: Low vs. moderate glycemic index in people with Nutrition and Sport, run by Poznan University of Life Sciences at 1 site in Poland.
Trial summary
The purpose of the present study was to assess the influence of low vs moderate glycemic index of a 3-week diet on aerobic capacity, endurance performance and body mass and composition in endurance-trained athletes in a randomized, controlled crossover trial. Read more about this study
- Who is it for?
- Ages 17 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Sport, Glycemic Index
- What is being tested?
- Dietary Intervention: Low vs. moderate glycemic index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2015to 1 May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 37 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Life Sciences, ul.Wojska Polskiego 31
Poznan, Wielkopolska, 60-624
About this study
Official title: Effects of Low and Versus Moderate Glycemic Index Diets on Physical Capacity and Body Composition in Endurance- Trained Runners
The purpose of the present study was to assess the influence of low vs moderate glycemic index of a 3-week diet on aerobic capacity, endurance performance and body mass and composition in endurance-trained athletes in a randomized, controlled crossover trial.
Read the detailed description
The effect of glycemic index of pre-exercise meal on endurance capacity and performance has been widely investigated. However, little is known about the adaptations to longer dietary interventions with different glycemic index and their influence on aerobic capacity and body composition in runners. Therefore, the purpose of this study was the assessment of the influence of low GI vs moderate GI of a 3-week diet on aerobic capacity, endurance performance and body mass and composition in endurance-trained athletes in a randomised, controlled crossover trial.
- Conditions
- Nutrition, Sport, Glycemic Index, Physical Capacity
- Being tested
- Dietary Intervention: Low vs. moderate glycemic index
- Keywords
- Nutrition, Training support, Low Glycemic Index, Moderate Glycemic Index, Endurance, Running
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Intervention: Low vs. moderate glycemic indexOther
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Index Diet | Experimental | 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. Receives: Other: Dietary Intervention: Low vs. moderate glycemic index |
| Moderate Glycemic Index Diet | Experimental | 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. Receives: Other: Dietary Intervention: Low vs. moderate glycemic index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in aerobic capacity following low glycemic index diet
Measured: Baseline and after 3 weeks
Changes in aerobic capacity following moderate glycemic index diet
Measured: Baseline and after 3 weeks
Changes in performance in 12-min running test following low glycemic index diet
Measured: Baseline and after 3 weeks
Changes in performance in 12-min running test following moderate glycemic index diet
Measured: Baseline and after 3 weeks
Changes in fat mass and fat free mass following low glycemic index diet
Fat mass (kg) and fat free mass (kg) analysis
Measured: Baseline and after 3 weeks
Changes in fat mass and fat free mass following moderate glycemic index diet
Fat mass (kg) and fat free mass (kg) analysis
Measured: Baseline and after 3 weeks
Secondary outcomes (3)
Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
Measured: 1 year
Statistical evaluation of the significance of differences between the changes in performance in 12-min running test
Measured: 1 year
Statistical evaluation of the significance of differences between the changes in fat mass and fat free mass
Fat mass (kg) and fat free mass (kg)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJan 2015
- Primary completion6 Feb 2015
- Study completion1 May 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krzysztof Durkalec-Michalski, PhD, Poznan University of Life Sciences
- Investigators
- Jan Jeszka, Professor, Study chair, Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062527
- Sponsor's protocol ID
- ULS00001
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Shared data will be exclusively related to the level recorded indicators (body composition, aerobic capacity, performance in 12-min running test), without personal data. Depending on the requirements of the journal, the data obtained will be attached to scientific publications, deposited in a public repository or provided by principal investigator when requested.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low and Versus Moderate Glycemic Index Diets on Physical Capacity and Body Composition in Endurance- Trained Runners
- ClinicalTrials.gov ID
- NCT03062527
- Acronym / sponsor ID
- ULS00001
- Conditions
- Nutrition, Sport, Glycemic Index, Physical Capacity
- Keywords
- Nutrition, Training support, Low Glycemic Index, Moderate Glycemic Index, Endurance, Running
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 6 Feb 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study was to assess the influence of low vs moderate glycemic index of a 3-week diet on aerobic capacity, endurance performance and body mass and composition in endurance-trained athletes in a randomized, controlled crossover trial.
Detailed description
The effect of glycemic index of pre-exercise meal on endurance capacity and performance has been widely investigated. However, little is known about the adaptations to longer dietary interventions with different glycemic index and their influence on aerobic capacity and body composition in runners. Therefore, the purpose of this study was the assessment of the influence of low GI vs moderate GI of a 3-week diet on aerobic capacity, endurance performance and body mass and composition in endurance-trained athletes in a randomised, controlled crossover trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Index Diet | Experimental | Other: Dietary Intervention: Low vs. moderate glycemic indexGroup 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. |
| Moderate Glycemic Index Diet | Experimental | Other: Dietary Intervention: Low vs. moderate glycemic indexGroup 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. |
Who may qualify
- Ages
- 17 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary Intervention: Low vs. moderate glycemic index | Other | Low Glycemic Index Diet, Moderate Glycemic Index Diet |
Primary outcome
Changes in aerobic capacity following low glycemic index diet
Time frame: Baseline and after 3 weeks
Changes in aerobic capacity following moderate glycemic index diet
Time frame: 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
Changes in performance in 12-min running test following moderate glycemic index diet
Time frame: Baseline and after 3 weeks
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
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
3 secondary outcomes
Statistical evaluation of the significance of differences between the changes in aerobic capacity indices
Time frame: 1 year
Statistical evaluation of the significance of differences between the changes in performance in 12-min running test
Time frame: 1 year
Statistical evaluation of the significance of differences between the changes in fat mass and fat free mass
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided. Shared data will be exclusively related to the level recorded indicators (body composition, aerobic capacity, performance in 12-min running test), without personal data. Depending on the requirements of the journal, the data obtained will be attached to scientific publications, deposited in a public repository or provided by principal investigator when requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Jeszka, Professor study chair
Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention: Low vs. moderate glycemic index in people with Nutrition and Sport, run by Poznan University of Life Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in aerobic capacity following low glycemic index diet (time frame: Baseline and after 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.