Hydration and Exercise Performance in Cycling

October 11, 2018 updated by: University of Exeter

How Does Altering the Composition of Ingested Fluids Affect Hydration Status Whilst Cycling?

This study will evaluate the effects manipulating ingested fluids can have on hydration status and cycling performance. There will be 4 different conditions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Being dehydrated can decrease endurance exercise performance. The investigators wish to test which of three drinks is most effective at re-hydrating cyclists and if this affects performance. Subjects will undertake 4 tests: once dehydrated, once hydrated with water, once hydrated with a sports-specific drink, and once with an altered sports drink. Blood samples will be taken and expired gasses will be sampled at various time points throughout the tests for later analysis. A small amount of labelled water will be consumed with each drink, a technique which will allow us to quantify the absorption of each of the drinks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Exeter, Devon, United Kingdom, EX1 2LU
        • School of Sports and Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Highly trained cyclists (vo2max >55 ml/kg/min, PPO (peak power output) > 4 w/kg)
  • Training at least 4 times a week
  • Females must be taking an oral contraceptive, or using the contraceptive implant

Exclusion Criteria:

  • Recent history of musculoskeletal injury
  • Diagnosed cardiovascular disease
  • Regular use of nutritional supplements that may interfere with the protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dehydrated
90 minutes cycling, without the ingestion of any fluids, followed by a 15 minute cycling time trial test
Other: Dehydrated
N/A: see arm description
Experimental: Hypotonic
90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g sucrose, 3g glucose) drinks, followed by a 15 minute cycling time trial test
Dietary supplement: Hypotonic
N/A: see arm description
Experimental: Isotonic
90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g glucose, 3g fructose) drinks, followed by a 15 minute cycling time trial test
Dietary supplement: Isotonic
N/A: see arm description
Experimental: Placebo
90 minutes cycling, with the ingestion of six 250 ml taste-matched water drinks, followed by a 15 minute cycling time trial test
Dietary supplement: Placebo
N/A: see arm description

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Absorption of fluid through the gut
Time Frame: To begin 10 minutes after the completion of the 90 minute steady-state cycle
Absorption of drinks through the gut will be measured using 2 boluses of deuterated water. This will be consumed alongside 2 of the drinks, and blood samples will be used to quantify enrichment. Total body water calculations are required to provide corrections in equations related to D2O. H218O will be consumed in order to quantify total body water: this will be provided in a single bolus before each trial.
To begin 10 minutes after the completion of the 90 minute steady-state cycle

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Work done (kJ) during 15 minute cycling time-trial
Time Frame: Throughout the 90 minute steady-state cycle & the 15 minute time trial.
Subjects will perform a cycle ergometer protocol that has been shown to be reproducible in athletes. Subjects will complete the time trial on a Lode Excalibur cycling ergometer. Software linked to this software will record work done and power output.
Throughout the 90 minute steady-state cycle & the 15 minute time trial.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Substrate utilisation
Time Frame: Throughout the 90 minute steady-state cycle
Substrate utilisation will be calculated from data collected through a metabolic cart and its software. It will be measured during the 90-minute steady-state cycle for 4 periods of 3 minutes. Carbohydrate and lipid oxidation rates will be calculated using equations by Jeukendrup & Wallis (2005).
Throughout the 90 minute steady-state cycle
Plasma metabolites
Time Frame: Throughout the 90 minute steady-state cycle and time-trial
A cannula will be used to draw blood from subjects at several time points. Whole blood samples will be analysed immediately for plasma glucose, plasma lactate, haemoglobin content, haematocrit and plasma volume. Remaining whole blood will be centrifuged immediately and its plasma split into aliquots and stored in a -20°C freezer. At the end of the trial, plasma samples will be moved to a -80°C freezer for later analysis for sodium, glycerol, and NEFA.
Throughout the 90 minute steady-state cycle and time-trial
Heart rate
Time Frame: Throughout the 90 minute steady-state cycle and time-trial
Heart rate will be measured throughout with the use of a heart rate monitor.
Throughout the 90 minute steady-state cycle and time-trial
RPE (rating of perceived exertion)
Time Frame: Throughout the 90 minute steady-state cycle and time-trial
RPE will be measured using the Borg Scale.
Throughout the 90 minute steady-state cycle and time-trial
Core body temperature
Time Frame: Throughout the 90 minute steady-state cycle and time-trial
Core temperature will be measured throughout with the use of an ingestible core-body temperature pill (HQ Inc, FL, USA).
Throughout the 90 minute steady-state cycle and time-trial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Exeter

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew D Davenport, MSc, The University of Exeter

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 170614/A/01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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