NCT03062527

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

1 month

First QC Date

February 14, 2017

Last Update Submit

February 20, 2017

Conditions

Keywords

NutritionTraining supportLow Glycemic IndexModerate Glycemic IndexEnduranceRunning

Outcome Measures

Primary Outcomes (6)

  • Changes in aerobic capacity following low glycemic index diet

    Baseline and after 3 weeks

  • Changes in aerobic capacity following moderate glycemic index diet

    Baseline and after 3 weeks

  • Changes in performance in 12-min running test following low glycemic index diet

    Baseline and after 3 weeks

  • Changes in performance in 12-min running test following moderate glycemic index diet

    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

    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

    Baseline and after 3 weeks

Secondary Outcomes (3)

  • Statistical evaluation of the significance of differences between the changes in aerobic capacity indices

    1 year

  • Statistical evaluation of the significance of differences between the changes in performance in 12-min running test

    1 year

  • Statistical evaluation of the significance of differences between the changes in fat mass and fat free mass

    1 year

Study Arms (2)

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.

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.

Other: Dietary Intervention: Low vs. moderate glycemic index

Interventions

Low Glycemic Index DietModerate Glycemic Index Diet

Eligibility Criteria

Age17 Years - 37 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

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)

Poznan University of Life Sciences, ul.Wojska Polskiego 31

Poznan, Wielkopolska, 60-624, Poland

Location

Study Officials

  • Jan Jeszka, Professor

    Department of Hygiene and Human Nutrition, Poznan University of Life Sciences, Poznan, Poland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 23, 2017

Study Start

January 1, 2015

Primary Completion

February 6, 2015

Study Completion

May 1, 2015

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations