- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06818253
Effect of Glycerol Hyperhydration on Running Economy of Long-distance Runners (GHLDR)
Effects of Glycerol Hyperhydration on Running Economy in Long-Distance Runners
The aim of this study was to evaluate the effects of hyperhydration with glycerol on running economy (RE) in trained runners. The main questions sought to be answered are:
- Does hyperhydration with glycerol improve running economy?
- Are there beneficial effects on physical performance?
The researchers will conduct a clinical trial with 30 runners (15 men, 15 women) in three sessions. In the first session, VO2peak was determined and running speeds were established for sessions 2 and 3. In the second session, participants performed a stress test. In the second session, participants performed a running test in the euhydrated state under fluid restriction, and in the third session, with glycerol supplementation (22 ml/kg sports drink + 1.2 g/kg glycerol). Variables such as caloric cost unit (CCU), oxygen cost unit (OCU), heart rate (HR), body temperature (BT) and perceived exertion (RPE) were evaluated.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jalisco
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Guadalajara, Jalisco, Mexico, 45425
- Universidad de Guadalajara, Centro Universitario de Tonalá
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Competitive runners with a minimum record of 4.2 min/km.
- Age between 18 and 35 years old
- Apparently healthy athletes
- Signature of informed consent form
Exclusion Criteria:
- Presence of comorbidities that could alter the study variables (such as arterial hypertension, hyperthyroidism or heart disease).
- Consumption of medications or stimulants (such as caffeine or diuretics) 48 hours before the tests.
Pregnancy.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm glycerol supplementation
This arm participated in a crossover design allowed minimizing interindividual variability by using each participant as their own control, evaluating the conditions of (1) hyperhydration with glycerol and (2) water restriction.
The main variables evaluated were maximal oxygen consumption (VO₂max), running economy (CE), calculated using the oxygen cost unit (OCU) and caloric cost unit (CCU), as well as body temperature, perception of exertion and sweating rate.
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The main factor that distinguishes this intervention is first of all the dosage of the dietary supplement and the effects on the variables to be analyzed related to physical performance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal oxygen consumption (VO₂peak) (ml/kg/min)
Time Frame: In the first evaluation session to be held in the first week of a total of 3 weeks of study duration
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Session 1: VO2peak measurements through an incremental treadmill test with 2 km/h speed increments every 3 minutes, maintaining a constant 1% incline.
The test started at 6 km/h for all participants and continued until volitional exhaustion
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In the first evaluation session to be held in the first week of a total of 3 weeks of study duration
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Running economy (CE)
Time Frame: In the first evaluation session to be held in the first week of a total of 3 weeks of study duration
|
Test under Hydration Restriction (No-GLY): As a mandatory requirement, participants reported to the laboratory in a euhydrated state (USG: 1.018-1.024) prior to the start of the test, following the criteria outlined in previous research [31]. They ran for 15 minutes on a treadmill at a speed equivalent to 65%-70% of their VO2peak from the first session. During the test, running economy variables such as the caloric cost unit (CCU), oxygen cost unit (OCU), body temperature (BT), rating of perceived exertion (RPE) via the Borg scale, and hydration status were measured. Running Economy Calculation: i) The caloric cost unit (CCU) was calculated via the following equation [25]: CCU =((VO2 x δ x 1000)/(V x MC)) x 100 where VO2 is the oxygen consumption rate (L/min); δ is the kcal/L of oxygen based on the respiratory exchange ratio (RER); V is the speed (m/min); and MC is the body mass (kg). |
In the first evaluation session to be held in the first week of a total of 3 weeks of study duration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body temperature
Time Frame: Body temperature was measured during sessions 2 (No Gly) and 3 (Gly) at the following times: at minute 0 (prior to the start of each test) and at minutes 5, 10 and 15 during a treadmill test.
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The temperature will be measured during the running economy evaluation with an infrared thermometer (Berrcom® JXB-178).
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Body temperature was measured during sessions 2 (No Gly) and 3 (Gly) at the following times: at minute 0 (prior to the start of each test) and at minutes 5, 10 and 15 during a treadmill test.
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Perception of exertion
Time Frame: It was applied during the evaluation of the stress tests to determine the Vo2peak and Running Economy.
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The Borg effort perception scale, with a range of scores from 6 to 20, was used during the three sessions, recording the perception of effort in each minute of the test according to the following classification:
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It was applied during the evaluation of the stress tests to determine the Vo2peak and Running Economy.
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Sweating rate.
Time Frame: In sessions 1 and 2, urine specific gravity (USG) was assessed, which was one of the key criteria for determining whether subjects could continue in the study without being eliminated.
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Fluctuations in body mass between the different sessions were evaluated.
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In sessions 1 and 2, urine specific gravity (USG) was assessed, which was one of the key criteria for determining whether subjects could continue in the study without being eliminated.
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Collaborators and Investigators
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IICDEM-ID-001-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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