NCT02103491

Brief Summary

Background: Ultradistance athletes frequently consume salt supplements during competitions to compensate the loss of electrolytes by sweating. The aim of this study was to investigate the effectiveness of oral salt supplementation to improve exercise performance during a half-ironman triathlon. Methodology: Twenty-six experienced triathletes were matched for age, anthropometric data and training status and randomly placed into the salt group (113 mmol Na+ and 112 mmol Cl-) or the control group (cellulose). The experimental treatments were provided in unidentifiable capsules and were ingested before and during the race. Participants competed in a real half-ironman triathlon and race time was measured by means of chip timing. Pre and post-race, body mass, maximal force during a whole-body isometric strength test, maximal height during a countermovement jump, and blood samples were obtained. Sweat samples were obtained during the running section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

March 26, 2014

Last Update Submit

August 29, 2023

Conditions

Keywords

Half-ironmanTriathlonSaltExercisePerformance

Outcome Measures

Primary Outcomes (3)

  • Triathlon race time

    Participants will compete in a real half-ironman triathlon and race time will be measured by means of chip timing. The chip timing will be adjusted in the participants's shoe. Race time will be measured in seconds.

    The experiment will be carried out in 1 day. This variable will be obtained in this unique experimental day.

  • Changes in blood parameters before and after the race

    The serum portion of each blood sample will be analyzed for osmolality (1249, Advance 3MO, Spain), sodium, chloride, potassium and magnesium concentrations (Nova 16, NovaBiomedical, Spain). ). In addition, the serum creatine kinase concentration will be measured as a blood marker of muscle damage by means of an autoanalyzer (AU5400, Beckman Coulter, US). Blood concentration (in mM) will be determined for each variable.

    The experiment will be carried out in 1 day. This variable will be obtained in this unique experimental day

  • Sweat samples analysis

    The sweat will be obtained with sweat patches (Tegaderm 3m) and it will be separated from the patches by centrifugation (10 min at 3000 g), transferred to 5-mL sealed tubes and refrigerated at 4 ºC. At a later date (within 2 days of the race), sweat osmolality will be measured with the same osmometer employed for the serum samples while sweat electrolyte concentration were measured using an ion selective electrode analyzer (Cobas 6000, Roche, Madrid, Spain). Sweat electrolyte concentration will be measured in mM.

    The experiment will be carried out in 1 day. This variable will be obtained in this unique experimental day

Secondary Outcomes (2)

  • Changes in total body water content (pre and post-race)

    The experiment will be carried out in 1 day. This variable will be obtained in this unique experimental day

  • Changes in whole body isometric force from pre to post-race

    The experiment will be carried out in 1 day. This variable will be obtained in this unique experimental day

Study Arms (2)

Salt administration

ACTIVE COMPARATOR

Participants were provided with 3 plastic bags each one containing 4 white capsules (e.g., a total of 12 capsules). In the salt group, the capsules were filled with a commercially available product that contains buffered electrolyte salts (Saltstick caps, Saltstick, California US). The total amount of electrolytes provided in the salt group was: 2580 mg of sodium (113 mmol), 3979 mg of chloride (112 mmol), 756 mg of potassium (19.3 mmol) and 132 mg of magnesium (5.4 mmol).

Dietary Supplement: Salt administration

Placebo administration

PLACEBO COMPARATOR

In the control group, participants received the same number of capsules with the exact same appearance but filled with an isocaloric placebo (cellulose).

Dietary Supplement: Placebo administration

Interventions

Salt administrationDIETARY_SUPPLEMENT

Participants were provided with 3 plastic bags each one containing 4 white capsules (e.g., a total of 12 capsules). In the salt group, the capsules were filled with a commercially available product that contains buffered electrolyte salts (Saltstick caps, Saltstick, California US). The total amount of electrolytes provided in the salt group was: 2580 mg of sodium (113 mmol), 3979 mg of chloride (112 mmol), 756 mg of potassium (19.3 mmol) and 132 mg of magnesium (5.4 mmol). In the control group, participants received the same number of capsules with the exact same appearance but filled with an isocaloric placebo (cellulose). All the participants were instructed to ingest the contents of the first bag in the transition between the swimming and cycling sections, the second bag around the middle of the cycling leg and the third bag during the transition between the cycling and running sections.

Salt administration
Placebo administrationDIETARY_SUPPLEMENT
Placebo administration

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Triathletes with previous experience in half-ironman

You may not qualify if:

  • Potential participants (triathletes) with a previous history of muscle disorder, cardiac or kidney disease or those taking medicines or supplements during the two prior weeks were discarded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Physiology Laboratory, Camilo Jose Cela University

Villanueva de la Cañada, Madrid, 28692, Spain

Location

Related Publications (1)

  • Del Coso J, Gonzalez-Millan C, Salinero JJ, Abian-Vicen J, Areces F, Lledo M, Lara B, Gallo-Salazar C, Ruiz-Vicente D. Effects of oral salt supplementation on physical performance during a half-ironman: A randomized controlled trial. Scand J Med Sci Sports. 2016 Feb;26(2):156-64. doi: 10.1111/sms.12427. Epub 2015 Feb 14.

MeSH Terms

Conditions

HyponatremiaMotor Activity

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Officials

  • Juan Del Coso, PhD

    Camilo Jose Cela University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2014

First Posted

April 4, 2014

Study Start

June 1, 2013

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations