Clinical trial NCT04206579: Oral Dextrose Formula in Performance of Soccer Athlete
Official title: Oral 10% Dextrose Versus Sodium Dextrose Formula in Performance of Soccer Athlete. A Double-Blind Cross Over Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletes
Keywords: Oral Dextrose
Blood Sugar
Sprint Velocity
Athletes
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: the study involves two different groups with a cross-over design. Each participant will be given an oral formula according to the group allocation followed by outcome measurement. After the wash-out period, the formula will be switched and given to the participants, followed by outcome measurement
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Blood Glucose
timeFrame: Blood Glucose Level at 15 minutes after intake
Secondary outcomes:
measure: Sprint Velocity
timeFrame: Sprint Velocity 30 minutes after intervention
measure: Volume O2 maximum (VO2 Max)
timeFrame: VO2 10 minutes after sprint
Other outcomes:
Locations:
city: Makasar
country: Indonesia
facility: Makassar State University
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Agussalim Bukhari, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
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