Performance Enhancing Product UseNCT05295836
Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes
A study testing GLYCEROL in people with Performance Enhancing Product Use and Change, Body Weight, run by Francisco Javier Martínez Noguera at 1 site in Spain.
Trial summary
This clinical study evaluates the acute effect of glycerol ingestion on performance (power output), weight, urine specific gravity, biochemical (antioxidants and lactate) and metabolic (indirect calorimetry) markers in international athletes in hot conditions. Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Performance Enhancing Product Use, Change, Body Weight, Change, Body Temperature
- What is being tested?
- GLYCEROL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2022to 25 Feb 2022
- 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 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be an international athlete with the Spanish national athletics team.
Who cannot join
- Are smokers or regular alcohol drinkers,
- Have a metabolic, cardiorespiratory or digestive pathology or anomaly,
- Have an injury in the prior 6 months
- Are supplementing or medicating in the prior 2 weeks
- Have non-normal values in the blood analysis parameters.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Research Center for High Performance Sport. Catholic University of Murcia
La Ñora, Murcia, 30830
About this study
This clinical study evaluates the acute effect of glycerol ingestion on performance (power output), weight, urine specific gravity, biochemical (antioxidants and lactate) and metabolic (indirect calorimetry) markers in international athletes in hot conditions. The investigators hypothesized that acute glycerol ingestion can prevent performance loss (power generated at submaximal intensity) in hot conditions. To justify this hypothesis, the investigators will measure the aforementioned markers, which could establish a cause-effect relationship between acute glycerol intake and decreased performance loss in hot conditions.
Read the detailed description
All participants will be informed about the procedures and provide signed informed consent. The study will be conducted according to the guidelines of the Helsinki Declaration for Human Research and the protocol was approved by the Ethics Committee/Institutional Review Catholic University of Murcia (Code: CE091802).
Study design
This is a randomized crossover study. There are 3 types of intervention: water intake of 26 mL/kg/weight at 16°C (CON), 26 mL/kg/weight + placebo at 28°C (PLA) and intake of 1.2 g glycerol + 26 mL/kg/weight at 28°C (GLY). In addition, athletes will be instructed to take a individualized diet in relation to macronutrients (verified by dietary record) and they will follow their adjusted training schedule so that there would be no effect on the tests. Participants in both groups will be instructed not to consume supplements 3 weeks prior to the start of the study.
Procedures
Participants will visit the laboratory on five occasions. Visit 1 consists of a medical examination and a blood draw to determine health status. At visit 2, after a dinner the night before and a standard breakfast, an incremental test will be performed to determine the exercise zones in the rectangular test. At visits 3, 4 and 5, a record of the diet (individually set) will be performed regarding the former 7 days, followed by a rectangular treadmill test.
Visit 1:
Health status blood test: A general blood test will be performed. The blood will be drawn through a vein. (Fasting) Medical examination: A medical history of family and personal history, an electrocardiogram (ECG) at rest and a medical examination (auscultation, blood pressure, etc.) will be carried out to certify that the person is healthy and is not at risk to participate in the study. (Fasting)
Visits 2:
Incremental test with final ramp test will be performed on a cycle ergometer using a metabolic cart (Metalyzer 3B. Leipzig, Germany) to determine maximal fat oxidation zone (FatMax), ventilatory thresholds 1 (VT1) and 2 (VT2) and maximal oxygen consumption (VO2max). Participants will begin cycling at 35W for 2 min, increasing then by 35W every 2 min until RER>1.05, initializing then the final ramp (+35W·min-1) until exhaustion.
Visits 3:
The rectangular test will be performed on a treadmill using the speed values obtained in the incremental test (15 sets x 2 min at 95% with 2:30 recovery at 85% of maximum speed between sets). Cardiorespiratory variables (VO2, VCO2, VO2R, VE/VO2, VE/VCO2, VE/VCO2, respiratory coefficient, respiratory frequency, carbohydrate oxidation (CHO), fat oxidation (FAT), running economy and energy expenditure) will be determined in the 1st, 5th, 10th and 15th series.
For power measurement, each participant will wear the Stryd power meter, which is an inertial sensor (9.1 g) mounted on the foot, firmly attached to the shoe and according to the manufacturer's recommendations. The device stores at a sampling rate of 1 Hz the following variables: estimated power (PO), pace, cadence, leg sprint stiffness (LSS), form power, form power ratio, ground contact time (GCT), vertical oscillation, stride length. These variables will then be determined in the 1st, 5th, 10th and 15th series of the rectangular test. According to information from the Stryd team, the device is operational out of the box and should not require any calibration, accepting a measurement error of 3 percent. Participants will fill in their height and body mass prior to use, which is required for PO estimation. The firmware version that will be used is 2.1.16 (released in August 2020).
For lactate and antioxidant measurements, a Lactate Pro 2 meter and eBQC lab will be used on finger capillary blood at rest, after the 5th, 10th and after completion of the rectangular test.
For body temperature, the investigators will use an infrared thermographic camera (FLIR) to measure heat distribution (head, trunk, lower and upper limbs in both anterior and posterior aspects of the body).
Urine Samples Urine will be collected from the intake of water or water + glycerol or water + placebo until the start of the rectangular test and up to one hour after the rectangular test. The volume of urine excreted pre and post rectangular test will be recorded and the urine specific gravity will be analyzed.
- Conditions
- Performance Enhancing Product Use, Change, Body Weight, Change, Body Temperature, Antioxidative Stress, Lactate Blood Increase, Thermal Sensation Disorders
- Being tested
- PLACEBO, GLYCEROL
- Keywords
- Power, Performance, Thermography, Metabolism, Endurance Sport, Ergogenic Aids, Oxygen uptake, Hydration, Hyperhydration
- Medical subject headings
- Body Weight Changes, Body Temperature Changes, Hyperlactatemia, Somatosensory Disorders, Water Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLACEBOOther
Athletes will perform the rectangular test at a temperature of 28°C and ingested 26 mL/kg body weight + placebo one and half hours before the test.
GLYCEROLDietary supplement
Athletes will perform the rectangular test at a temperature of 28°C and ingested 26 mL/kg body weight + 1.2 g of glycerol one and half hours before the test.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | No intervention | In this phase of the study, the rectangular test will be performed in conditions of 16°C and 25-30% humidity, intaking 26 mL/kg/body weight of water one and a half hours before the test. |
| PLACEBO (PLA) | Placebo comparator | In this intervention, subjects will perform the rectangular test at 28°C and 25-30% humidity, ingesting 26 mL/kg/body weight of water and placebo one and a half hours before the test. Receives: Other: PLACEBO |
| GLYCEROL (GLY) | Experimental | In this intervention, subjects will perform the rectangular test at 28°C and 25-30% humidity, ingesting 1.2 g + 26 mL/kg/body weight of water one and a half hours before the test. Receives: Dietary Supplement: GLYCEROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Record body weight before and after the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Urine specific gravity
Record urine specific gravity by means a digital refractometer (Atago) before and after the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Power output
Record the power produced by means the stryd sensor (shoe) in the 1st, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Body temperature
Record body temperature by thermography of the head, trunk, and lower limbs, anterior and posterior in rest, after 5th and 10th series, and after completion of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Secondary outcomes (21)
Lactate
Record lactate in rest, after 5th and 10th series, and after completion of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Measurement of fast- and slow-acting antioxidants (Q1 and Q2) and total antioxidant capacity by a portable analyzer eBQC0101
Record the antioxidant markers in rest, after 5th and 10th series, and after completion of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Heart rate
Record the heart rat in rest,1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
VO2
Record the oxygen uptake (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
CO2
Record the carbon dioxide exhalation (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
RER
Record respiratory exchange ratio in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
VE
Record ventilation (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
FAT ox
Record fat oxidation (g/h) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
HC ox
Record carbohydrate oxidation (g/h) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
FR
Record respiratory frequency (breaths/min) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
EE
Record energy expenditure (kcal/h) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
V'E/V'O2
Record ventilatory equivalents for oxygen (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
V'E/V'CO2
Record ventilatory equivalents for carbon dioxide (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
VO2/R
Record oxygen consumption relative to weight (mL/min/kg) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Cadence
Record cadence (steps per minute) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Leg spring stiffness
Record leg spring stiffness (kN/m) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Form power ratio
Record form power ratio in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Form power
Record form power (W) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Ground contact time
Record ground contact time (ms) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Vertical oscillation
Record vertical oscillation (cm) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
PO/R
Record power output relative to weight (W/kg) in 1th, 5th, 10th and 15th series of the rectangular test
Measured: Throughout study completion, an average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start10 Feb 2022
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance Enhancing Product UseStudies 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
- A randomized crossover study will be conducted, in which 4 international walkers will perform 3 different conditions: CON) water intake of 26 mL/kg/weight at 16°C; PLA) 26 mL/kg/weight + placebo at 28°C and GLY) intake of 1.2 g glycerol + 26 mL/kg/weight at 28°C.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francisco Javier Martínez Noguera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Javier Martínez Noguera, Universidad Católica San Antonio de Murcia
- Investigators
- Francisco Javier Martínez Noguera, PhD, Study chair, Research Center for High Performance Sport. Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295836
- Sponsor's protocol ID
- CE102102
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes
- ClinicalTrials.gov ID
- NCT05295836
- Acronym / sponsor ID
- CE102102
- Conditions
- Performance Enhancing Product Use, Change, Body Weight, Change, Body Temperature, Antioxidative Stress, Lactate Blood Increase, Thermal Sensation Disorders
- Keywords
- Power, Performance, Thermography, Metabolism, Endurance Sport, Ergogenic Aids, Oxygen uptake, Hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Francisco Javier Martínez NogueraUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 25 Mar 2022 (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.
This clinical study evaluates the acute effect of glycerol ingestion on performance (power output), weight, urine specific gravity, biochemical (antioxidants and lactate) and metabolic (indirect calorimetry) markers in international athletes in hot conditions. The investigators hypothesized that acute glycerol ingestion can prevent performance loss (power generated at submaximal intensity) in hot conditions. To justify this hypothesis, the investigators will measure the aforementioned markers, which could establish a cause-effect relationship between acute glycerol intake and decreased performance loss in hot conditions.
Detailed description
All participants will be informed about the procedures and provide signed informed consent. The study will be conducted according to the guidelines of the Helsinki Declaration for Human Research and the protocol was approved by the Ethics Committee/Institutional Review Catholic University of Murcia (Code: CE091802).
Study design
This is a randomized crossover study. There are 3 types of intervention: water intake of 26 mL/kg/weight at 16°C (CON), 26 mL/kg/weight + placebo at 28°C (PLA) and intake of 1.2 g glycerol + 26 mL/kg/weight at 28°C (GLY). In addition, athletes will be instructed to take a individualized diet in relation to macronutrients (verified by dietary record) and they will follow their adjusted training schedule so that there would be no effect on the tests. Participants in both groups will be instructed not to consume supplements 3 weeks prior to the start of the study.
Procedures
Participants will visit the laboratory on five occasions. Visit 1 consists of a medical examination and a blood draw to determine health status. At visit 2, after a dinner the night before and a standard breakfast, an incremental test will be performed to determine the exercise zones in the rectangular test. At visits 3, 4 and 5, a record of the diet (individually set) will be performed regarding the former 7 days, followed by a rectangular treadmill test.
Visit 1:
Health status blood test: A general blood test will be performed. The blood will be drawn through a vein. (Fasting) Medical examination: A medical history of family and personal history, an electrocardiogram (ECG) at rest and a medical examination (auscultation, blood pressure, etc.) will be carried out to certify that the person is healthy and is not at risk to participate in the study. (Fasting)
Visits 2:
Incremental test with final ramp test will be performed on a cycle ergometer using a metabolic cart (Metalyzer 3B. Leipzig, Germany) to determine maximal fat oxidation zone (FatMax), ventilatory thresholds 1 (VT1) and 2 (VT2) and maximal oxygen consumption (VO2max). Participants will begin cycling at 35W for 2 min, increasing then by 35W every 2 min until RER>1.05, initializing then the final ramp (+35W·min-1) until exhaustion.
Visits 3:
The rectangular test will be performed on a treadmill using the speed values obtained in the incremental test (15 sets x 2 min at 95% with 2:30 recovery at 85% of maximum speed between sets). Cardiorespiratory variables (VO2, VCO2, VO2R, VE/VO2, VE/VCO2, VE/VCO2, respiratory coefficient, respiratory frequency, carbohydrate oxidation (CHO), fat oxidation (FAT), running economy and energy expenditure) will be determined in the 1st, 5th, 10th and 15th series.
For power measurement, each participant will wear the Stryd power meter, which is an inertial sensor (9.1 g) mounted on the foot, firmly attached to the shoe and according to the manufacturer's recommendations. The device stores at a sampling rate of 1 Hz the following variables: estimated power (PO), pace, cadence, leg sprint stiffness (LSS), form power, form power ratio, ground contact time (GCT), vertical oscillation, stride length. These variables will then be determined in the 1st, 5th, 10th and 15th series of the rectangular test. According to information from the Stryd team, the device is operational out of the box and should not require any calibration, accepting a measurement error of 3 percent. Participants will fill in their height and body mass prior to use, which is required for PO estimation. The firmware version that will be used is 2.1.16 (released in August 2020).
For lactate and antioxidant measurements, a Lactate Pro 2 meter and eBQC lab will be used on finger capillary blood at rest, after the 5th, 10th and after completion of the rectangular test.
For body temperature, the investigators will use an infrared thermographic camera (FLIR) to measure heat distribution (head, trunk, lower and upper limbs in both anterior and posterior aspects of the body).
Urine Samples Urine will be collected from the intake of water or water + glycerol or water + placebo until the start of the rectangular test and up to one hour after the rectangular test. The volume of urine excreted pre and post rectangular test will be recorded and the urine specific gravity will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A randomized crossover study will be conducted, in which 4 international walkers will perform 3 different conditions: CON) water intake of 26 mL/kg/weight at 16°C; PLA) 26 mL/kg/weight + placebo at 28°C and GLY) intake of 1.2 g glycerol + 26 mL/kg/weight at 28°C.
| Arm | Type | Receives |
|---|---|---|
| CONTROL | No intervention | –In this phase of the study, the rectangular test will be performed in conditions of 16°C and 25-30% humidity, intaking 26 mL/kg/body weight of water one and a half hours before the test. |
| PLACEBO (PLA) | Placebo comparator | Other: PLACEBOIn this intervention, subjects will perform the rectangular test at 28°C and 25-30% humidity, ingesting 26 mL/kg/body weight of water and placebo one and a half hours before the test. |
| GLYCEROL (GLY) | Experimental | Dietary Supplement: GLYCEROLIn this intervention, subjects will perform the rectangular test at 28°C and 25-30% humidity, ingesting 1.2 g + 26 mL/kg/body weight of water one and a half hours before the test. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Be an international athlete with the Spanish national athletics team.
Key exclusion criteria (5 listed)
- Are smokers or regular alcohol drinkers,
- Have a metabolic, cardiorespiratory or digestive pathology or anomaly,
- Have an injury in the prior 6 months
- Are supplementing or medicating in the prior 2 weeks
- Have non-normal values in the blood analysis parameters.
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 |
|---|---|---|
| PLACEBOAthletes will perform the rectangular test at a temperature of 28°C and ingested 26 mL/kg body weight + placebo one and half hours before the test. | Other | PLACEBO (PLA) |
| GLYCEROLAthletes will perform the rectangular test at a temperature of 28°C and ingested 26 mL/kg body weight + 1.2 g of glycerol one and half hours before the test. | Dietary supplement | GLYCEROL (GLY) |
Primary outcome
Body weight
Time frame: Throughout study completion, an average of 3 weeks
Record body weight before and after the rectangular test
Urine specific gravity
Time frame: Throughout study completion, an average of 3 weeks
Record urine specific gravity by means a digital refractometer (Atago) before and after the rectangular test
Power output
Time frame: Throughout study completion, an average of 3 weeks
Record the power produced by means the stryd sensor (shoe) in the 1st, 5th, 10th and 15th series of the rectangular test
Body temperature
Time frame: Throughout study completion, an average of 3 weeks
Record body temperature by thermography of the head, trunk, and lower limbs, anterior and posterior in rest, after 5th and 10th series, and after completion of the rectangular test
21 secondary outcomes
Lactate
Time frame: Throughout study completion, an average of 3 weeks
Measurement of fast- and slow-acting antioxidants (Q1 and Q2) and total antioxidant capacity by a portable analyzer eBQC0101
Time frame: Throughout study completion, an average of 3 weeks
Heart rate
Time frame: Throughout study completion, an average of 3 weeks
VO2
Time frame: Throughout study completion, an average of 3 weeks
CO2
Time frame: Throughout study completion, an average of 3 weeks
RER
Time frame: Throughout study completion, an average of 3 weeks
VE
Time frame: Throughout study completion, an average of 3 weeks
FAT ox
Time frame: Throughout study completion, an average of 3 weeks
HC ox
Time frame: Throughout study completion, an average of 3 weeks
FR
Time frame: Throughout study completion, an average of 3 weeks
EE
Time frame: Throughout study completion, an average of 3 weeks
V'E/V'O2
Time frame: Throughout study completion, an average of 3 weeks
V'E/V'CO2
Time frame: Throughout study completion, an average of 3 weeks
VO2/R
Time frame: Throughout study completion, an average of 3 weeks
Cadence
Time frame: Throughout study completion, an average of 3 weeks
Leg spring stiffness
Time frame: Throughout study completion, an average of 3 weeks
Form power ratio
Time frame: Throughout study completion, an average of 3 weeks
Form power
Time frame: Throughout study completion, an average of 3 weeks
Ground contact time
Time frame: Throughout study completion, an average of 3 weeks
Vertical oscillation
Time frame: Throughout study completion, an average of 3 weeks
PO/R
Time frame: Throughout study completion, an average of 3 weeks
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 25 Mar 2022.
- Research Center for High Performance Sport. Catholic University of MurciaLink provided by the sponsor.
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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.
Francisco Javier Martínez Noguera, PhD study chair
Research Center for High Performance Sport. Catholic University of Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLYCEROL in people with Performance Enhancing Product Use and Change, Body Weight, run by Francisco Javier Martínez Noguera at 1 site in Spain.
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 1 inclusion and 5 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 25 Mar 2022. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Body weight (time frame: Throughout study completion, an average of 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2022.