- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03948230
Hypo-hydration Mood and Cognition
10. maj 2019 opdateret af: David Benton, Swansea University
Hypo-hydration, Mood and Cognition: the Effect of the Colour and Type of Drink
Recently changes in mood and cognition have been reported following minor reductions in hydration status.
The aim is to explore that such changes in part at least reflect placebo response; therefore the consumption of plain or coloured water will be compared in drinks designed to differ in their ability to rehydrate.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
162 individuals will be subject to a temperature of 30°C for three hours, and mood and cognition monitored.
Randomly on two occasions they will consume no drink or 300ml of plain or red colored water.
In addition they will take a capsule containing sodium chloride or a placebo.
Mood will be monitored using visual analogue scales and a battery of cognitive tests will be completed on three occasions: attention, episodic and working memory, reactions times.
Urine osmolality will be measured at the beginning and end of the study and changes in body mass will be recorded.
Changes in functioning will be related to the nature of the drink and changes in osmolality and body mass.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
162
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Wales
-
Swansea, Wales, Det Forenede Kongerige, sa2 8pp
- Rekruttering
- Psychology, Swansea University
-
Swansea, Wales, Det Forenede Kongerige, SA2 8PP
- Rekruttering
- Swansea University
-
Kontakt:
- David Benton, DSc
- Telefonnummer: ++44 1792 295607
- E-mail: d.benton@swansea.ac.uk
-
Kontakt:
- Sara Long, B.Sc.
- Telefonnummer: ++44 1792 295278
- E-mail: 444451@swansea.ac.uk
-
-
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 30 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
- 18 to 30 years
- Non-smokers
- BMI < 30
- By self-report in good health
- Not taking medication for any psychological or other health disorder.
Exclusion Criteria:
- Do not meet inclusion criteria
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Sodium chloride / Water
300mg sodium chloride consumed in a capsule on two occasions with 300ml water
|
Drinks with and without a salt containing capsule
|
|
Aktiv komparator: Sodium chloride / no water
300 mg sodium chloride consumed
|
Drinks with and without a salt containing capsule
|
|
Aktiv komparator: Sodium chloride / colored water
300mg sodium chloride consumed in a capsule on two occasions with 300ml coloured water
|
Drinks with and without a salt containing capsule
|
|
Placebo komparator: Placebo / water
Placebo consumed in a capsule on two occasions with 300ml water
|
Drinks with and without a salt containing capsule
|
|
Placebo komparator: Placebo / no water
Placebo capsule consumed
|
Drinks with and without a salt containing capsule
|
|
Placebo komparator: Placebo / coloured water
Placebo consumed in a capsule on two occasions with 300ml colored water
|
Drinks with and without a salt containing capsule
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mood rating: agreeable / hostile
Tidsramme: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words agreeable/hostile and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
|
Changes from baseline after 90 and 180 minutes
|
|
Mood rating: confused / clearheaded
Tidsramme: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words confused / clearheaded and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
|
Changes from baseline after 90 and 180 minutes
|
|
Mood rating: composed / anxious
Tidsramme: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words composed / anxious and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
|
Changes from baseline after 90 and 180 minutes
|
|
Mood rating: depressed / elated
Tidsramme: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words depressed / elated and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
|
Changes from baseline after 90 and 180 minutes
|
|
Mood rating: tired / energetic
Tidsramme: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words tired / energetic and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
|
Changes from baseline after 90 and 180 minutes
|
|
Mood rating: confident / unsure
Tidsramme: Changes from baseline after 90 and 180 minutes
|
A hundred millimetre lines will be anchored with the words confident / unsure and the subject will rate their mood by marking the line.. My measuring in millimetres a score between 0 and 100 will result with a higher score indicating a more positive mood.
|
Changes from baseline after 90 and 180 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Episodic memory
Tidsramme: Changes from baseline after 90 and 180 minutes
|
A list of 30 words will be presented after which the subject writes down as many as can be recalled.
The resulting score will vary from 0-30.
|
Changes from baseline after 90 and 180 minutes
|
|
Serial Sevens; test of working memory
Tidsramme: Changes from baseline after 90 and 180 minutes
|
28 numbers each of three digits will be presented and the subject indicates whether a subsequent number was exactly seven less.
The measure reported is the response time in milli-seconds taken to respond
|
Changes from baseline after 90 and 180 minutes
|
|
Attention: Arrow Flankers
Tidsramme: Changes from baseline after 90 and 180 minutes
|
A series is presented that can be >>>>> or >><>> and the subject has to indicated whether the middle symbol points to the right or left.
The measure reported is the time taken to respond in milli-seconds
|
Changes from baseline after 90 and 180 minutes
|
|
Reaction times
Tidsramme: Changes from baseline after 90 and 180 minutes
|
The time to press a button under an illuminated light was recorded in milli-seconds when there was 1, 2, 4, or 8 possible lamps that could be lit.
20 trials were performed with each of the four number of lights.
|
Changes from baseline after 90 and 180 minutes
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: David Benton, DSc, Professor of Psychology
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)
1. januar 2018
Primær færdiggørelse (Forventet)
31. juli 2019
Studieafslutning (Forventet)
31. juli 2019
Datoer for studieregistrering
Først indsendt
8. maj 2019
Først indsendt, der opfyldte QC-kriterier
10. maj 2019
Først opslået (Faktiske)
13. maj 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. maj 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. maj 2019
Sidst verificeret
1. maj 2019
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- DB-0519
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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