- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03304197
Hydration and Exercise Performance in Cycling
11. oktober 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
15
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Devon
-
Exeter, Devon, Det Forenede Kongerige, EX1 2LU
- School of Sports and Health Sciences
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 50 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Dehydrated
90 minutes cycling, without the ingestion of any fluids, followed by a 15 minute cycling time trial test
|
N/A: see arm description
|
Eksperimentel: 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
|
N/A: see arm description
|
Eksperimentel: 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
|
N/A: see arm description
|
Eksperimentel: Placebo
90 minutes cycling, with the ingestion of six 250 ml taste-matched water drinks, followed by a 15 minute cycling time trial test
|
N/A: se armbeskrivelse
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Absorption of fluid through the gut
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Work done (kJ) during 15 minute cycling time-trial
Tidsramme: 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.
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Substrate utilisation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Andrew D Davenport, MSc, The University of Exeter
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. september 2017
Primær færdiggørelse (Faktiske)
1. juni 2018
Studieafslutning (Faktiske)
1. juni 2018
Datoer for studieregistrering
Først indsendt
13. september 2017
Først indsendt, der opfyldte QC-kriterier
2. oktober 2017
Først opslået (Faktiske)
6. oktober 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. oktober 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. oktober 2018
Sidst verificeret
1. oktober 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 170614/A/01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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