## Protocol Section
### Identification Module
**NCT ID:** NCT04206579

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 0611192027
#### Organization
**Class:** OTHER
**Full Name:** Hasanuddin University
### Status Module
#### Completion Date
**Date:** 2019-06-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-12-20

**Type:** ACTUAL

**Last Update Submit Date:** 2019-12-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-05-28

**Type:** ACTUAL

#### Start Date
**Date:** 2019-03-25

**Type:** ACTUAL

**Status Verified Date:** 2019-12

#### Study First Post Date
**Date:** 2019-12-20
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-12
**Study First Submit QC Date:** 2019-12-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hasanuddin University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Athletes

**Keywords:**

- Oral Dextrose

- Blood Sugar

- Sprint Velocity

- Athletes

### Design Module

#### Design Info

**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

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Both packages of intervention have a similar dimension to ensure the participants are not recognizing the formula. The pharmacists are responsible for preparing the formula and given to the nurse prior to the intervention. Investigators are being masked during the whole intervention.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Oral 10% Dextrose

**Intervention Names:**

- Drug: 10% Dextrose

- Drug: Natrium Dextrose

**Label:** 10% Dextrose

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Oral Natrium Dextrose

**Intervention Names:**

- Drug: 10% Dextrose

- Drug: Natrium Dextrose

**Label:** Natrium Dextrose

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 10% Dextrose

- Natrium Dextrose

**Description:** A mixture of 150 cc dextrose 10% in oral formulation

**Name:** 10% Dextrose

**Other Names:**

- Unavailable Information

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 10% Dextrose

- Natrium Dextrose

**Description:** A mixture of 150 cc dextrose 10% + 20 cc sodium in oral formulation

**Name:** Natrium Dextrose

**Other Names:**

- Unavailable Information

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Blood Glucose measured in capillary blood vessels

**Measure:** Blood Glucose

**Time Frame:** Blood Glucose Level at 15 minutes after intake

#### Secondary Outcomes

**Description:** maximum sprint speed

**Measure:** Sprint Velocity

**Time Frame:** Sprint Velocity 30 minutes after intervention

**Description:** Maximum (MAX) volume (V) of oxygen (O2) an individual body in incremental exercise

**Measure:** Volume O2 maximum (VO2 Max)

**Time Frame:** VO2 10 minutes after sprint

### Eligibility Module

**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%.

**Gender Based:** True

**Gender Description:** Male at birth

**Healthy Volunteers:** True

**Maximum Age:** 23 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Makasar

**Country:** Indonesia

**Facility:** Makassar State University

**State:** South Sulawesi

**Zip:** 90222

#### Overall Officials

**Official 1:**

**Affiliation:** Hasanuddin University

**Name:** Agussalim Bukhari, MD, Ph.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** No individual participant data (IPD) will be shared

**IPD Sharing:** NO

### References Module

#### References

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## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
