Oral Dextrose Formula in Performance of Soccer Athlete

December 19, 2019 updated by: Hasanuddin University

Oral 10% Dextrose Versus Sodium Dextrose Formula in Performance of Soccer Athlete. A Double-Blind Cross Over Randomized Controlled Trial

I. Title of Proposed Research Project Dextrose 10% Drink Increase Blood Sugar and Sprint Velocity Compared to Sodium Dextrose in Soccer Players

II. Specific Aims This study aims to evaluate the ergogenic effect in terms of blood sugar, VO2 max and sprint speed of dextrose 10% compared with sodium dextrose 10% in young male soccer players.

III. Background Sports drinks are designed to provide CHO, electrolytes, and fluids to the body, which are absorbed very fast from the small intestine. In other words, the period from ingestion until the CHO, electrolytes, and fluids reach the muscles, brain and so on, should be very short. This is the most important advantage of using sports drinks (Simulescu, Ilia, Macarie, & Merghes, 2019). Commercial sports drinks generally contain both of CHO and sodium; To the best of the investigator's knowledge, there is no trial in which compare the differential effect of solely dextrose supplementation versus sodium dextrose in soccer players in terms of BG concentration, VO2 max and sprint speed, which may give a new paradigm for the available ergogenic sports drink.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Male academy soccer players, included in a trial, received two types of solutions (compound of 150 cc dextrose 10% + 20 mM sodium or single 150 cc dextrose 10%) interchangeably, separated within 120 minutes were completed in a counterbalanced, randomized, double-blind, crossover design. The study was approved by the Faculty of Medicine Hasanuddin University Research Ethics Committee. This trial was conducted at UNM Banta-Bantaeng, Makassar, Indonesia, from April 2019 to May 2019. All participants were within the last meal four hours prior to the test. Exclusion criteria were the use of amylase supplement, suffering from fever and diarrhea, using laxative agents within 24 h, consuming CHO absorption inhibitors, caffeine, creatinine, beta alanine, sodium bicarbonate supplement within 24 h, mean arterial pressure <65mmHg, knee or muscle injuries, history of diabetes mellitus and heart disease, going through ketogenic diet program, history of gastrointestinal surgery, and total body fat percentages > 30%.

Dietary intake was collected using two days food recall. BG were measured using portable glucometer (Aviva; Accucheck, Roche Diagnostics, Indiana, U.S.A), blood pressure were measured using aneroid sphygmomanometer (R1 shock-proof; Riester, Jungingen, Germany), heart rate were measured with wrist band pulse monitor (Bluetooth 4.0 wireless sport heart rate monitor WP290; Egoman, Shenzen, China), body weight, muscle, fat, water, metabolic rate were measured using body composition analyzer (BC-545N; Tanita, Tokyo, Japan), body height were measured using stadiometer (HR-200, Tanita, Tokyo, Japan), sprint speed were measured using digital stopwatch (S23589 S23589P1; Seiko, Tokyo, Japan) Participants were instructed to refrain from strenuous physical activity in the 2 days preceding trial sessions and recorded all food consumed in the 2 days before the trial. Food records subsequently were analyzed using professional German nutrition software (EBISpro, Nutrisurvey 2007). On arrival at the field, pre supplementation capillary blood samples were collected, and then all players run for 2x100 m and calculated the VO2max using Uth-Sorenen-Overgaard-Pedersen Formula and sprint speed was recorded. After doing the baseline measurement, each player waited for 15 minutes in order to consume either dextrose or sodium dextrose solution, and then waited for 15 minutes to had another subsequent capillary blood samples measurement. After that, the players run for 2x100 m, recorded the VO2max and sprint speed. The players remained in a rested state for 120 minutes as a crossover washed-out period, and then did the same protocol with different solution.

All data are expressed as mean ± SD unless otherwise stated, with 95% confidence interval, and significance was accepted at p < 0.05. Data were checked for normality as indicated by the Shapiro-Wilk test. Paired t tests were used to compare before and after condition in blood sugar, VO2max and sprint speed. Data was analysed using IBM SPSS Statistics software, version 25; IBM Corp., Chicago, IL. To interpret the magnitude of effect, Cohen's d effect sizes (±95% confidence limits) were estimated using a purpose built spreadsheet, with effect size thresholds set at <0.20, >0.50, and >0.80 for small, moderate, large, effects respectively.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Indonesia
    • South Sulawesi
      • Makasar, South Sulawesi, Indonesia, 90222
        • Makassar State University

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 23 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male
  2. Age 18-23 years.
  3. Soccer player
  4. Last meal a maximum of 4 hours before
  5. Willing and signed an agreement to participate in research.

Exclusion Criteria:

  1. The use of amylase supplement
  2. Suffering from fever and diarrhea
  3. Using laxative agents within 24 h
  4. Consuming CHO absorption inhibitors, Caffeine, creatinine, beta-alanine, sodium bicarbonate supplement within 24 h,
  5. Mean arterial pressure <65mmHg
  6. Knee or muscle injuries,
  7. History of diabetes mellitus and heart disease
  8. Going through the ketogenic diet program.
  9. History of gastrointestinal surgery, and total body fat percentages > 30%.

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 10% Dextrose
Oral 10% Dextrose
Drug: 10% Dextrose
A mixture of 150 cc dextrose 10% in oral formulation
Other Names:
  • Unavailable Information
Drug: Natrium Dextrose
A mixture of 150 cc dextrose 10% + 20 cc sodium in oral formulation
Other Names:
  • Unavailable Information
Experimental: Natrium Dextrose
Oral Natrium Dextrose
Drug: 10% Dextrose
A mixture of 150 cc dextrose 10% in oral formulation
Other Names:
  • Unavailable Information
Drug: Natrium Dextrose
A mixture of 150 cc dextrose 10% + 20 cc sodium in oral formulation
Other Names:
  • Unavailable Information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Glucose
Time Frame: Blood Glucose Level at 15 minutes after intake
Blood Glucose measured in capillary blood vessels
Blood Glucose Level at 15 minutes after intake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sprint Velocity
Time Frame: Sprint Velocity 30 minutes after intervention
maximum sprint speed
Sprint Velocity 30 minutes after intervention
Volume O2 maximum (VO2 Max)
Time Frame: VO2 10 minutes after sprint
Maximum (MAX) volume (V) of oxygen (O2) an individual body in incremental exercise
VO2 10 minutes after sprint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasanuddin University

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.

General Publications

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)

March 25, 2019

Primary Completion (Actual)

May 28, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 19, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0611192027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual participant data (IPD) will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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