NCT04206579

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
Last Updated

December 20, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

December 12, 2019

Last Update Submit

December 19, 2019

Conditions

Keywords

Oral DextroseBlood SugarSprint VelocityAthletes

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose

    Blood Glucose measured in capillary blood vessels

    Blood Glucose Level at 15 minutes after intake

Secondary Outcomes (2)

  • Sprint Velocity

    Sprint Velocity 30 minutes after intervention

  • Volume O2 maximum (VO2 Max)

    VO2 10 minutes after sprint

Study Arms (2)

10% Dextrose

EXPERIMENTAL

Oral 10% Dextrose

Drug: 10% DextroseDrug: Natrium Dextrose

Natrium Dextrose

EXPERIMENTAL

Oral Natrium Dextrose

Drug: 10% DextroseDrug: Natrium Dextrose

Interventions

A mixture of 150 cc dextrose 10% in oral formulation

Also known as: Unavailable Information
10% DextroseNatrium Dextrose

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

Also known as: Unavailable Information
10% DextroseNatrium Dextrose

Eligibility Criteria

Age18 Years - 23 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale at birth
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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 the ketogenic diet program.
  • History of gastrointestinal surgery, and total body fat percentages \> 30%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makassar State University

Makassar, South Sulawesi, 90222, Indonesia

Location

Related Publications (39)

  • Achten J, Halson SL, Moseley L, Rayson MP, Casey A, Jeukendrup AE. Higher dietary carbohydrate content during intensified running training results in better maintenance of performance and mood state. J Appl Physiol (1985). 2004 Apr;96(4):1331-40. doi: 10.1152/japplphysiol.00973.2003. Epub 2003 Dec 5.

    PMID: 14660506BACKGROUND
  • Afshar N, Safaei S, Nickerson DP, Hunter PJ, Suresh V. Computational Modeling of Glucose Uptake in the Enterocyte. Front Physiol. 2019 Apr 12;10:380. doi: 10.3389/fphys.2019.00380. eCollection 2019.

    PMID: 31031632BACKGROUND
  • Amann M. Pulmonary system limitations to endurance exercise performance in humans. Exp Physiol. 2012 Mar;97(3):311-8. doi: 10.1113/expphysiol.2011.058800. Epub 2011 Nov 28.

    PMID: 22125308BACKGROUND
  • Baker LB, Rollo I, Stein KW, Jeukendrup AE. Acute Effects of Carbohydrate Supplementation on Intermittent Sports Performance. Nutrients. 2015 Jul 14;7(7):5733-63. doi: 10.3390/nu7075249.

    PMID: 26184303BACKGROUND
  • Bangsbo J, Iaia FM, Krustrup P. Metabolic response and fatigue in soccer. Int J Sports Physiol Perform. 2007 Jun;2(2):111-27. doi: 10.1123/ijspp.2.2.111.

    PMID: 19124899BACKGROUND
  • Boyd CA, Parsons DS. Movements of monosaccharides between blood and tissues of vascularly perfused small intestine. J Physiol. 1979 Feb;287:371-91. doi: 10.1113/jphysiol.1979.sp012665.

    PMID: 430421BACKGROUND
  • Burke LM, Meyer NL, Pearce J. National Nutritional Programs for the 2012 London Olympic Games: a systematic approach by three different countries. Nestle Nutr Inst Workshop Ser. 2013;76:103-20. doi: 10.1159/000350263. Epub 2013 Jul 25.

    PMID: 23899758BACKGROUND
  • Dobbins RL, Greenway FL, Chen L, Liu Y, Breed SL, Andrews SM, Wald JA, Walker A, Smith CD. Selective sodium-dependent glucose transporter 1 inhibitors block glucose absorption and impair glucose-dependent insulinotropic peptide release. Am J Physiol Gastrointest Liver Physiol. 2015 Jun 1;308(11):G946-54. doi: 10.1152/ajpgi.00286.2014. Epub 2015 Mar 12.

    PMID: 25767259BACKGROUND
  • Esposito BP, Breuer W, Sirankapracha P, Pootrakul P, Hershko C, Cabantchik ZI. Labile plasma iron in iron overload: redox activity and susceptibility to chelation. Blood. 2003 Oct 1;102(7):2670-7. doi: 10.1182/blood-2003-03-0807. Epub 2003 Jun 12.

    PMID: 12805056BACKGROUND
  • F Alghannam, A. (2013). Physiology of Soccer: The Role of Nutrition in Performance. Journal of Novel Physiotherapies. https://doi.org/10.4172/2165-7025.s3-003

    BACKGROUND
  • Gabbett TJ, Mulvey MJ. Time-motion analysis of small-sided training games and competition in elite women soccer players. J Strength Cond Res. 2008 Mar;22(2):543-52. doi: 10.1519/JSC.0b013e3181635597.

    PMID: 18550972BACKGROUND
  • Godek SF, Peduzzi C, Burkholder R, Condon S, Dorshimer G, Bartolozzi AR. Sweat rates, sweat sodium concentrations, and sodium losses in 3 groups of professional football players. J Athl Train. 2010 Jul-Aug;45(4):364-71. doi: 10.4085/1062-6050-45.4.364.

    PMID: 20617911BACKGROUND
  • Hills SP, Russell M. Carbohydrates for Soccer: A Focus on Skilled Actions and Half-Time Practices. Nutrients. 2017 Dec 25;10(1):22. doi: 10.3390/nu10010022.

    PMID: 29295583BACKGROUND
  • Jentjens RL, Achten J, Jeukendrup AE. High oxidation rates from combined carbohydrates ingested during exercise. Med Sci Sports Exerc. 2004 Sep;36(9):1551-8. doi: 10.1249/01.mss.0000139796.07843.1d.

    PMID: 15354037BACKGROUND
  • Jeukendrup A. A step towards personalized sports nutrition: carbohydrate intake during exercise. Sports Med. 2014 May;44 Suppl 1(Suppl 1):S25-33. doi: 10.1007/s40279-014-0148-z.

    PMID: 24791914BACKGROUND
  • Jeukendrup AE. Training the Gut for Athletes. Sports Med. 2017 Mar;47(Suppl 1):101-110. doi: 10.1007/s40279-017-0690-6.

    PMID: 28332114BACKGROUND
  • Kellett GL. The facilitated component of intestinal glucose absorption. J Physiol. 2001 Mar 15;531(Pt 3):585-95. doi: 10.1111/j.1469-7793.2001.0585h.x.

    PMID: 11251042BACKGROUND
  • Kellett GL, Brot-Laroche E. Apical GLUT2: a major pathway of intestinal sugar absorption. Diabetes. 2005 Oct;54(10):3056-62. doi: 10.2337/diabetes.54.10.3056.

    PMID: 16186415BACKGROUND
  • Kellett GL, Brot-Laroche E, Mace OJ, Leturque A. Sugar absorption in the intestine: the role of GLUT2. Annu Rev Nutr. 2008;28:35-54. doi: 10.1146/annurev.nutr.28.061807.155518.

    PMID: 18393659BACKGROUND
  • Kimmich GA, Randles J. Sodium-sugar coupling stoichiometry in chick intestinal cells. Am J Physiol. 1984 Jul;247(1 Pt 1):C74-82. doi: 10.1152/ajpcell.1984.247.1.C74.

    PMID: 6331188BACKGROUND
  • Kingsley M, Penas-Ruiz C, Terry C, Russell M. Effects of carbohydrate-hydration strategies on glucose metabolism, sprint performance and hydration during a soccer match simulation in recreational players. J Sci Med Sport. 2014 Mar;17(2):239-43. doi: 10.1016/j.jsams.2013.04.010. Epub 2013 May 20.

    PMID: 23702257BACKGROUND
  • Mace OJ, Affleck J, Patel N, Kellett GL. Sweet taste receptors in rat small intestine stimulate glucose absorption through apical GLUT2. J Physiol. 2007 Jul 1;582(Pt 1):379-92. doi: 10.1113/jphysiol.2007.130906. Epub 2007 May 10.

    PMID: 17495045BACKGROUND
  • Mace OJ, Morgan EL, Affleck JA, Lister N, Kellett GL. Calcium absorption by Cav1.3 induces terminal web myosin II phosphorylation and apical GLUT2 insertion in rat intestine. J Physiol. 2007 Apr 15;580(Pt. 2):605-16. doi: 10.1113/jphysiol.2006.124784. Epub 2007 Feb 1.

    PMID: 17272349BACKGROUND
  • MacLeod RJ, Hamilton JR. Volume regulation initiated by Na(+)-nutrient cotransport in isolated mammalian villus enterocytes. Am J Physiol. 1991 Jan;260(1 Pt 1):G26-33. doi: 10.1152/ajpgi.1991.260.1.G26.

    PMID: 1702936BACKGROUND
  • Naftalin RJ. Does apical membrane GLUT2 have a role in intestinal glucose uptake? F1000Res. 2014 Dec 12;3:304. doi: 10.12688/f1000research.5934.1. eCollection 2014.

    PMID: 25671087BACKGROUND
  • Naftalin RJ. A computer model simulating human glucose absorption and metabolism in health and metabolic disease states. F1000Res. 2016 Apr 12;5:647. doi: 10.12688/f1000research.8299.1. eCollection 2016.

    PMID: 27347379BACKGROUND
  • Roder PV, Geillinger KE, Zietek TS, Thorens B, Koepsell H, Daniel H. The role of SGLT1 and GLUT2 in intestinal glucose transport and sensing. PLoS One. 2014 Feb 26;9(2):e89977. doi: 10.1371/journal.pone.0089977. eCollection 2014.

    PMID: 24587162BACKGROUND
  • Russell M, Rees G, Benton D, Kingsley M. An exercise protocol that replicates soccer match-play. Int J Sports Med. 2011 Jul;32(7):511-8. doi: 10.1055/s-0031-1273742. Epub 2011 Apr 6.

    PMID: 21472627BACKGROUND
  • Russell M, Benton D, Kingsley M. Influence of carbohydrate supplementation on skill performance during a soccer match simulation. J Sci Med Sport. 2012 Jul;15(4):348-54. doi: 10.1016/j.jsams.2011.12.006. Epub 2012 Jan 9.

    PMID: 22230353BACKGROUND
  • Russell M, Benton D, Kingsley M. Carbohydrate ingestion before and during soccer match play and blood glucose and lactate concentrations. J Athl Train. 2014 Jul-Aug;49(4):447-53. doi: 10.4085/1062-6050-49.3.12. Epub 2014 Jun 16.

    PMID: 24933430BACKGROUND
  • Russell M, Kingsley M. The efficacy of acute nutritional interventions on soccer skill performance. Sports Med. 2014 Jul;44(7):957-70. doi: 10.1007/s40279-014-0184-8.

    PMID: 24728928BACKGROUND
  • Seidelmann SB, Feofanova E, Yu B, Franceschini N, Claggett B, Kuokkanen M, Puolijoki H, Ebeling T, Perola M, Salomaa V, Shah A, Coresh J, Selvin E, MacRae CA, Cheng S, Boerwinkle E, Solomon SD. Genetic Variants in SGLT1, Glucose Tolerance, and Cardiometabolic Risk. J Am Coll Cardiol. 2018 Oct 9;72(15):1763-1773. doi: 10.1016/j.jacc.2018.07.061.

    PMID: 30286918BACKGROUND
  • Simulescu, V., Ilia, G., Macarie, L., & Merghes, P. (2019). Sport and energy drinks consumption before, during and after training. Science and Sports, 34(1), 3-9. https://doi.org/10.1016/j.scispo.2018.10.002

    BACKGROUND
  • Pfeiffer B, Stellingwerff T, Zaltas E, Jeukendrup AE. Oxidation of solid versus liquid CHO sources during exercise. Med Sci Sports Exerc. 2010 Nov;42(11):2030-7. doi: 10.1249/MSS.0b013e3181e0efc9.

    PMID: 20404762BACKGROUND
  • Thazhath SS, Wu T, Young RL, Horowitz M, Rayner CK. Glucose absorption in small intestinal diseases. Expert Rev Gastroenterol Hepatol. 2014 Mar;8(3):301-12. doi: 10.1586/17474124.2014.887439. Epub 2014 Feb 6.

    PMID: 24502537BACKGROUND
  • Thomas DT, Erdman KA, Burke LM. American College of Sports Medicine Joint Position Statement. Nutrition and Athletic Performance. Med Sci Sports Exerc. 2016 Mar;48(3):543-68. doi: 10.1249/MSS.0000000000000852.

    PMID: 26891166BACKGROUND
  • Thorsen K, Drengstig T, Ruoff P. Transepithelial glucose transport and Na+/K+ homeostasis in enterocytes: an integrative model. Am J Physiol Cell Physiol. 2014 Aug 15;307(4):C320-37. doi: 10.1152/ajpcell.00068.2013. Epub 2014 Jun 4.

    PMID: 24898586BACKGROUND
  • Scribbans TD, Vecsey S, Hankinson PB, Foster WS, Gurd BJ. The Effect of Training Intensity on VO2max in Young Healthy Adults: A Meta-Regression and Meta-Analysis. Int J Exerc Sci. 2016 Apr 1;9(2):230-247. doi: 10.70252/HHBR9374. eCollection 2016.

    PMID: 27182424BACKGROUND
  • Zisko N, Stensvold D, Hordnes-Slagsvold K, Rognmo O, Nauman J, Wisloff U, Karlsen T. Effect of Change in VO2max on Daily Total Energy Expenditure in a Cohort of Norwegian Men: A Randomized Pilot Study. Open Cardiovasc Med J. 2015 Apr 30;9:50-7. doi: 10.2174/1874192401509010050. eCollection 2015.

    PMID: 25969700BACKGROUND

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Agussalim Bukhari, MD, Ph.D

    Hasanuddin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 20, 2019

Study Start

March 25, 2019

Primary Completion

May 28, 2019

Study Completion

June 30, 2019

Last Updated

December 20, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

No individual participant data (IPD) will be shared

Locations