NCT05295836

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

15 days

First QC Date

February 24, 2022

Last Update Submit

March 15, 2022

Conditions

Keywords

PowerPerformanceThermographyMetabolismEndurance SportErgogenic AidsOxygen uptakeHydrationHyperhydration

Outcome Measures

Primary Outcomes (4)

  • Body weight

    Record body weight before and after the rectangular test

    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

    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

    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

    Throughout study completion, an average of 3 weeks

Secondary Outcomes (21)

  • Lactate

    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

    Throughout study completion, an average of 3 weeks

  • Heart rate

    Throughout study completion, an average of 3 weeks

  • VO2

    Throughout study completion, an average of 3 weeks

  • CO2

    Throughout study completion, an average of 3 weeks

  • +16 more secondary outcomes

Study Arms (3)

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.

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.

Dietary Supplement: GLYCEROL

Interventions

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.

PLACEBO (PLA)
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.

GLYCEROL (GLY)

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be an international athlete with the Spanish national athletics team.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center for High Performance Sport. Catholic University of Murcia

La Ñora, Murcia, 30830, Spain

Location

Related Links

MeSH Terms

Conditions

Body Weight ChangesBody Temperature ChangesHyperlactatemiaSomatosensory DisordersWater Intoxication

Interventions

Glycerol

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesWater-Electrolyte ImbalancePoisoningChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Francisco Javier Martínez Noguera, PhD

    Research Center for High Performance Sport. Catholic University of Murcia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study coordinator (Investigator)

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 25, 2022

Study Start

February 10, 2022

Primary Completion

February 25, 2022

Study Completion

February 25, 2022

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations