AthletesNCT04206579
Oral Dextrose Formula in Performance of Soccer Athlete
A study testing 10% Dextrose and Natrium Dextrose in people with Athletes, run by Hasanuddin University at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletes
- What is being tested?
- 10% Dextrose and Natrium Dextrose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Mar 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age 18-23 years.
- Soccer player
- Last meal a maximum of 4 hours before
- Willing and signed an agreement to participate in research.
Who cannot join
- 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,
Show all 9Show fewer
- History of diabetes mellitus and heart disease
- Going through the ketogenic diet program.
- History of gastrointestinal surgery, and total body fat percentages > 30%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral 10% Dextrose Versus Sodium Dextrose Formula in Performance of Soccer Athlete. A Double-Blind Cross Over Randomized Controlled Trial
- 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.
Read the 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
- Athletes
- Being tested
- 10% Dextrose, Natrium Dextrose
- Keywords
- Oral Dextrose, Blood Sugar, Sprint Velocity, Athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10% DextroseDrug
Also called Unavailable Information
A mixture of 150 cc dextrose 10% in oral formulation
Natrium DextroseDrug
Also called Unavailable Information
A mixture of 150 cc dextrose 10% + 20 cc sodium in oral formulation
| Study group | Role | What they receive |
|---|---|---|
| 10% Dextrose | Experimental | Oral 10% Dextrose Receives: Drug: 10% Dextrose; Drug: Natrium Dextrose |
| Natrium Dextrose | Experimental | Oral Natrium Dextrose Receives: Drug: 10% Dextrose; Drug: Natrium Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Blood Glucose measured in capillary blood vessels
Measured: Blood Glucose Level at 15 minutes after intake
Secondary outcomes (2)
Sprint Velocity
maximum sprint speed
Measured: Sprint Velocity 30 minutes after intervention
Volume O2 maximum (VO2 Max)
Maximum (MAX) volume (V) of oxygen (O2) an individual body in incremental exercise
Measured: VO2 10 minutes after sprint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start25 Mar 2019
- Primary completion28 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for AthletesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agussalim Bukhari, MD, Ph.D, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206579
- Sponsor's protocol ID
- 0611192027
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared
Publications
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.
PubMed 14660506Afshar 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.
PubMed 31031632Amann 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.
PubMed 22125308Baker 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.
PubMed 26184303Bangsbo 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.
PubMed 19124899Boyd 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.
PubMed 430421Burke 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.
PubMed 23899758Dobbins 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.
PubMed 25767259Esposito 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.
PubMed 12805056F 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
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.
PubMed 18550972Godek 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.
PubMed 20617911Hills 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.
PubMed 29295583Jentjens 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.
PubMed 15354037Jeukendrup 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.
PubMed 24791914
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral 10% Dextrose Versus Sodium Dextrose Formula in Performance of Soccer Athlete. A Double-Blind Cross Over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04206579
- Acronym / sponsor ID
- 0611192027
- Conditions
- Athletes
- Keywords
- Oral Dextrose, Blood Sugar, Sprint Velocity, Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 10% Dextrose | Experimental | Drug: 10% Dextrose, Drug: Natrium DextroseOral 10% Dextrose |
| Natrium Dextrose | Experimental | Drug: 10% Dextrose, Drug: Natrium DextroseOral Natrium Dextrose |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- Age 18-23 years.
- Soccer player
- Last meal a maximum of 4 hours before
- Willing and signed an agreement to participate in research.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10% DextroseAlso: Unavailable InformationA mixture of 150 cc dextrose 10% in oral formulation | Drug | 10% Dextrose, Natrium Dextrose |
| Natrium DextroseAlso: Unavailable InformationA mixture of 150 cc dextrose 10% + 20 cc sodium in oral formulation | Drug | 10% Dextrose, Natrium Dextrose |
Primary outcome
Blood Glucose
Time frame: Blood Glucose Level at 15 minutes after intake
Blood Glucose measured in capillary blood vessels
2 secondary outcomes
Sprint Velocity
Time frame: Sprint Velocity 30 minutes after intervention
Volume O2 maximum (VO2 Max)
Time frame: VO2 10 minutes after sprint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Background: PubMed 14660506Achten 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.
- Background: PubMed 31031632Afshar 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.
- Background: PubMed 22125308Amann 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.
- Background: PubMed 26184303Baker 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.
- Background: PubMed 19124899Bangsbo 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.
- Background: PubMed 430421Boyd 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.
- Background: PubMed 23899758Burke 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.
- Background: PubMed 25767259Dobbins 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.
- Background: PubMed 12805056Esposito 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.
- BackgroundF 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: PubMed 18550972Gabbett 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.
- Background: PubMed 20617911Godek 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.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agussalim Bukhari, MD, Ph.D principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10% Dextrose and Natrium Dextrose in people with Athletes, run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose (time frame: Blood Glucose Level at 15 minutes after intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04206579, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.