- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07921914
Dietary Supplementation and Hydration
This study will examine the effects of protein drinks on markers of hydration in healthy young males and females.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Leicestershire
-
Loughborough, Leicestershire, Det Forenede Kongerige
- Loughborough University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Healthy, physically active
Exclusion Criteria:
Are not between the ages of 18-40. If you are not considered at least recreationally physically active (at least meeting the WHO criteria) - Tier 1 or Tier 2 on the Participant Classification Framework (https://pubmed.ncbi.nlm.nih.gov/34965513/).
Have metabolic, inflammatory, vascular, renal disease or any other complication that would contradict the study procedures or risk your health.
Currently taking medication or supplements that may interfere with the study outcomes.
- Do not satisfactorily complete the health history survey
- You have any allergies to the ingredients in the supplements
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Protein
Protein (10 g of protein powder and 500 ml of water) |
10 g of protein powder in 500 ml water 10 g of protein powder, plus sodium chloride (20 mmol/L) in 500 ml of water |
|
Eksperimentel: Protein+
Protein (10 g of protein powder, 500 ml of water, sodium chloride, 20 mmol/L) |
10 g of protein powder in 500 ml water 10 g of protein powder, plus sodium chloride (20 mmol/L) in 500 ml of water |
|
Placebo komparator: Placebo control
Water (500 ml) |
Water (500 ml) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Urine output (mass in grams over 180 min collection period)
Tidsramme: 180 minutes
|
180 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Subjective measures of thirst (Likert scale, 0-10; 0 = low, 10 = high)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Urine specific gravity (AU)
Tidsramme: Pre - then 60, 120, 180 mins post
|
Pre - then 60, 120, 180 mins post
|
|
|
Blood sodium concentrations (mmol)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Blood chloride concentrations (mmol)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Blood potassium (mmol)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Urine sodium (mmol)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Urine chloride (mmol)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Urine potassium (mmol)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Plasma volume change (% change)
Tidsramme: Pre - then 60, 180 minutes
|
Pre - then 60, 180 minutes
|
|
|
Plasma albumin concentrations
Tidsramme: Pre - then 60, 180 minutes
|
ELISA measurement |
Pre - then 60, 180 minutes
|
|
Plasma aldosterone concentrations
Tidsramme: Pre - then 60, 180 minutes
|
ELISA measurement |
Pre - then 60, 180 minutes
|
|
Subjective measure of hunger (Likert scale, 0-10; 0 = low, 10 = high)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Subjective measure of gastrointestinal stress (Likert scale, 0-10; 0 = low, 10 = high)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Plasma insulin concentrations
Tidsramme: Pre - then 60, 180 minutes
|
ELISA measurement |
Pre - then 60, 180 minutes
|
|
Subjective measures of hunger (Likert scale, 0-10; 0 = low, 10 = high)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Subjective measures of stomach fullness (Likert scale, 0-10; 0 = low, 10 = high)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Subjective measures of nausea (Likert scale, 0-10; 0 = low, 10 = high)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
|
|
Beverage hydration index (AU)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Calculated as the ratio of cumulative urine mass for water/cumulative urine mass of the test beverages |
Pre - then 30, 60, 120, 180 mins post
|
|
Plasma osmolality (mOsm/L)
Tidsramme: Pre - 60, 180 mins post
|
Pre - 60, 180 mins post
|
|
|
Blood glucose (mmol/L)
Tidsramme: Pre - then 30, 60, 120, 180 mins post
|
Pre - then 30, 60, 120, 180 mins post
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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