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Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes

Primary Purpose

Performance Enhancing Product Use, Change, Body Weight, Change, Body Temperature

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PLACEBO
GLYCEROL
Sponsored by
Francisco Javier Martínez Noguera
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Performance Enhancing Product Use focused on measuring Power, Performance, Thermography, Metabolism, Endurance Sport, Ergogenic Aids, Oxygen uptake, Hydration, Hyperhydration

Eligibility Criteria

25 Years - 35 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Research Center for High Performance Sport. Catholic University of Murcia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

CONTROL

PLACEBO (PLA)

GLYCEROL (GLY)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Body weight
Record body weight before and after the rectangular test
Urine specific gravity
Record urine specific gravity by means a digital refractometer (Atago) before and after the rectangular test
Power output
Record the power produced by means the stryd sensor (shoe) in the 1st, 5th, 10th and 15th series of the rectangular test
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

Secondary Outcome Measures

Lactate
Record lactate in rest, after 5th and 10th series, and after completion of the rectangular test
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
Heart rate
Record the heart rat in rest,1th, 5th, 10th and 15th series of the rectangular test
VO2
Record the oxygen uptake (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
CO2
Record the carbon dioxide exhalation (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
RER
Record respiratory exchange ratio in 1th, 5th, 10th and 15th series of the rectangular test
VE
Record ventilation (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
FAT ox
Record fat oxidation (g/h) in 1th, 5th, 10th and 15th series of the rectangular test
HC ox
Record carbohydrate oxidation (g/h) in 1th, 5th, 10th and 15th series of the rectangular test
FR
Record respiratory frequency (breaths/min) in 1th, 5th, 10th and 15th series of the rectangular test
EE
Record energy expenditure (kcal/h) in 1th, 5th, 10th and 15th series of the rectangular test
V'E/V'O2
Record ventilatory equivalents for oxygen (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
V'E/V'CO2
Record ventilatory equivalents for carbon dioxide (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
VO2/R
Record oxygen consumption relative to weight (mL/min/kg) in 1th, 5th, 10th and 15th series of the rectangular test
Cadence
Record cadence (steps per minute) in 1th, 5th, 10th and 15th series of the rectangular test
Leg spring stiffness
Record leg spring stiffness (kN/m) in 1th, 5th, 10th and 15th series of the rectangular test
Form power ratio
Record form power ratio in 1th, 5th, 10th and 15th series of the rectangular test
Form power
Record form power (W) in 1th, 5th, 10th and 15th series of the rectangular test
Ground contact time
Record ground contact time (ms) in 1th, 5th, 10th and 15th series of the rectangular test
Vertical oscillation
Record vertical oscillation (cm) in 1th, 5th, 10th and 15th series of the rectangular test
PO/R
Record power output relative to weight (W/kg) in 1th, 5th, 10th and 15th series of the rectangular test

Full Information

First Posted
February 24, 2022
Last Updated
March 15, 2022
Sponsor
Francisco Javier Martínez Noguera
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1. Study Identification

Unique Protocol Identification Number
NCT05295836
Brief Title
Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes
Official Title
Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2022 (Actual)
Primary Completion Date
February 25, 2022 (Actual)
Study Completion Date
February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Francisco Javier Martínez Noguera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Hyperhydration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Participant
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
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.
Arm Title
PLACEBO (PLA)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
GLYCEROL (GLY)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PLACEBO
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
GLYCEROL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body weight
Description
Record body weight before and after the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Urine specific gravity
Description
Record urine specific gravity by means a digital refractometer (Atago) before and after the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Power output
Description
Record the power produced by means the stryd sensor (shoe) in the 1st, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Body temperature
Description
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
Time Frame
Throughout study completion, an average of 3 weeks
Secondary Outcome Measure Information:
Title
Lactate
Description
Record lactate in rest, after 5th and 10th series, and after completion of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Measurement of fast- and slow-acting antioxidants (Q1 and Q2) and total antioxidant capacity by a portable analyzer eBQC0101
Description
Record the antioxidant markers in rest, after 5th and 10th series, and after completion of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Heart rate
Description
Record the heart rat in rest,1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
VO2
Description
Record the oxygen uptake (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
CO2
Description
Record the carbon dioxide exhalation (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
RER
Description
Record respiratory exchange ratio in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
VE
Description
Record ventilation (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
FAT ox
Description
Record fat oxidation (g/h) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
HC ox
Description
Record carbohydrate oxidation (g/h) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
FR
Description
Record respiratory frequency (breaths/min) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
EE
Description
Record energy expenditure (kcal/h) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
V'E/V'O2
Description
Record ventilatory equivalents for oxygen (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
V'E/V'CO2
Description
Record ventilatory equivalents for carbon dioxide (L/min) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
VO2/R
Description
Record oxygen consumption relative to weight (mL/min/kg) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Cadence
Description
Record cadence (steps per minute) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Leg spring stiffness
Description
Record leg spring stiffness (kN/m) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Form power ratio
Description
Record form power ratio in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Form power
Description
Record form power (W) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Ground contact time
Description
Record ground contact time (ms) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
Vertical oscillation
Description
Record vertical oscillation (cm) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks
Title
PO/R
Description
Record power output relative to weight (W/kg) in 1th, 5th, 10th and 15th series of the rectangular test
Time Frame
Throughout study completion, an average of 3 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Javier Martínez Noguera, PhD
Organizational Affiliation
Research Center for High Performance Sport. Catholic University of Murcia
Official's Role
Study Chair
Facility Information:
Facility Name
Research Center for High Performance Sport. Catholic University of Murcia
City
La Ñora
State/Province
Murcia
ZIP/Postal Code
30830
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://investigacion.ucam.edu/vicerrectorado/ciard
Description
Research Center for High Performance Sport. Catholic University of Murcia

Learn more about this trial

Effects of Acute Glycerol Ingestion on Performance, Metabolic and Biochemical Markers in International Athletes

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