- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05295836
Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Murcia
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La Ñora, Murcia, Spain, 30830
- Research Center for High Performance Sport. Catholic University of Murcia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be an international athlete with the Spanish national athletics team.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: CONTROL
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.
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Placebo Comparator: PLACEBO (PLA)
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.
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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.
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Experimental: GLYCEROL (GLY)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body weight
Time Frame: Throughout study completion, an average of 3 weeks
|
Record body weight before and after the rectangular test
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Throughout study completion, an average of 3 weeks
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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
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Throughout study completion, an average of 3 weeks
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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
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Throughout study completion, an average of 3 weeks
|
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
|
Throughout study completion, an average of 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lactate
Time Frame: Throughout study completion, an average of 3 weeks
|
Record lactate in rest, after 5th and 10th series, and after completion of the rectangular test
|
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
|
Record the antioxidant markers in rest, after 5th and 10th series, and after completion of the rectangular test
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Throughout study completion, an average of 3 weeks
|
Heart rate
Time Frame: Throughout study completion, an average of 3 weeks
|
Record the heart rat in rest,1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
VO2
Time Frame: Throughout study completion, an average of 3 weeks
|
Record the oxygen uptake (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
|
Throughout study completion, an average of 3 weeks
|
CO2
Time Frame: Throughout study completion, an average of 3 weeks
|
Record the carbon dioxide exhalation (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
|
Throughout study completion, an average of 3 weeks
|
RER
Time Frame: Throughout study completion, an average of 3 weeks
|
Record respiratory exchange ratio in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
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VE
Time Frame: Throughout study completion, an average of 3 weeks
|
Record ventilation (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
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FAT ox
Time Frame: Throughout study completion, an average of 3 weeks
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Record fat oxidation (g/h) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
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HC ox
Time Frame: Throughout study completion, an average of 3 weeks
|
Record carbohydrate oxidation (g/h) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
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FR
Time Frame: Throughout study completion, an average of 3 weeks
|
Record respiratory frequency (breaths/min) in 1th, 5th, 10th and 15th series of the rectangular test
|
Throughout study completion, an average of 3 weeks
|
EE
Time Frame: Throughout study completion, an average of 3 weeks
|
Record energy expenditure (kcal/h) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
V'E/V'O2
Time Frame: Throughout study completion, an average of 3 weeks
|
Record ventilatory equivalents for oxygen (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
V'E/V'CO2
Time Frame: Throughout study completion, an average of 3 weeks
|
Record ventilatory equivalents for carbon dioxide (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
VO2/R
Time Frame: Throughout study completion, an average of 3 weeks
|
Record oxygen consumption relative to weight (mL/min/kg) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
Cadence
Time Frame: Throughout study completion, an average of 3 weeks
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Record cadence (steps per minute) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
Leg spring stiffness
Time Frame: Throughout study completion, an average of 3 weeks
|
Record leg spring stiffness (kN/m) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
Form power ratio
Time Frame: Throughout study completion, an average of 3 weeks
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Record form power ratio in 1th, 5th, 10th and 15th series of the rectangular test
|
Throughout study completion, an average of 3 weeks
|
Form power
Time Frame: Throughout study completion, an average of 3 weeks
|
Record form power (W) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
Ground contact time
Time Frame: Throughout study completion, an average of 3 weeks
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Record ground contact time (ms) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
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Vertical oscillation
Time Frame: Throughout study completion, an average of 3 weeks
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Record vertical oscillation (cm) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
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PO/R
Time Frame: Throughout study completion, an average of 3 weeks
|
Record power output relative to weight (W/kg) in 1th, 5th, 10th and 15th series of the rectangular test
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Throughout study completion, an average of 3 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Francisco Javier Martínez Noguera, PhD, Research Center for High Performance Sport. Catholic University of Murcia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE102102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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