HealthyNCT03304197
Hydration and Exercise Performance in Cycling
A study testing Hypotonic, Isotonic and Dehydrated in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
Trial summary
This study will evaluate the effects manipulating ingested fluids can have on hydration status and cycling performance. There will be 4 different conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Hypotonic, Isotonic and Dehydrated
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Sep 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Recent history of musculoskeletal injury
- Diagnosed cardiovascular disease
- Regular use of nutritional supplements that may interfere with the protocol
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sports and Health Sciences
Exeter, Devon, EX1 2LU
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Hypotonic, Isotonic, Placebo, Dehydrated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypotonicDietary supplement
N/A: see arm description
IsotonicDietary supplement
N/A: see arm description
PlaceboDietary supplement
N/A: see arm description
DehydratedOther
N/A: see arm description
| Study group | Role | What they receive |
|---|---|---|
| Dehydrated | Experimental | 90 minutes cycling, without the ingestion of any fluids, followed by a 15 minute cycling time trial test Receives: Other: Dehydrated |
| Hypotonic | Experimental | 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 Receives: Dietary Supplement: Hypotonic |
| Isotonic | Experimental | 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 Receives: Dietary Supplement: Isotonic |
| Placebo | Experimental | 90 minutes cycling, with the ingestion of six 250 ml taste-matched water drinks, followed by a 15 minute cycling time trial test Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption of fluid through the gut
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.
Measured: To begin 10 minutes after the completion of the 90 minute steady-state cycle
Secondary outcomes (1)
Work done (kJ) during 15 minute cycling 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.
Measured: Throughout the 90 minute steady-state cycle & the 15 minute time trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start11 Sep 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew D Davenport, MSc, Principal investigator, The University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304197
- Sponsor's protocol ID
- 170614/A/01
- Status last verified
- Oct 2018
- First submitted
- 13 Sep 2017
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Altering the Composition of Ingested Fluids Affect Hydration Status Whilst Cycling?
- ClinicalTrials.gov ID
- NCT03304197
- Acronym / sponsor ID
- 170614/A/01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects manipulating ingested fluids can have on hydration status and cycling performance. There will be 4 different conditions.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dehydrated | Experimental | Other: Dehydrated90 minutes cycling, without the ingestion of any fluids, followed by a 15 minute cycling time trial test |
| Hypotonic | Experimental | Dietary Supplement: Hypotonic90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g sucrose, 3g glucose) drinks, followed by a 15 minute cycling time trial test |
| Isotonic | Experimental | Dietary Supplement: Isotonic90 minutes cycling, with the ingestion of six 250 ml carbohydrate (6g glucose, 3g fructose) drinks, followed by a 15 minute cycling time trial test |
| Placebo | Experimental | Dietary Supplement: Placebo90 minutes cycling, with the ingestion of six 250 ml taste-matched water drinks, followed by a 15 minute cycling time trial test |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Recent history of musculoskeletal injury
- Diagnosed cardiovascular disease
- Regular use of nutritional supplements that may interfere with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypotonicN/A: see arm description | Dietary supplement | Hypotonic |
| IsotonicN/A: see arm description | Dietary supplement | Isotonic |
| PlaceboN/A: see arm description | Dietary supplement | Placebo |
| DehydratedN/A: see arm description | Other | Dehydrated |
Primary outcome
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.
1 secondary outcome
Work done (kJ) during 15 minute cycling time-trial
Time frame: Throughout the 90 minute steady-state cycle & the 15 minute time trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Davenport, MSc principal investigator
The University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotonic, Isotonic and Dehydrated in people with Healthy, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absorption of fluid through the gut (time frame: To begin 10 minutes after the completion of the 90 minute steady-state cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.