H2O – Hydration to Optimize with a Low Sodium Beverage
Descrizione riassuntiva dello studio
Hydration is important for our health as it supports many bodily functions and allows our organs to function optimally. The body typically loses about 2.6 liters of water per day through urine, skin, breathing, and feces. If these losses are not replaced by water intake, in the form of beverages or food, there is a risk of dehydration. Unfortunately, most current hydration solutions contain sugars and sodium, which can contribute to cardio-metabolic diseases. A new hydration solution containing whey protein, glycerol, and water has shown promising results in improving hydration status in studies involving cats and dogs. In this study, we aim to examine the effect of this new solution on hydration in healthy adults. The study will be conducted with 45 participants at the Clinical Innovation Laboratory following a double-blind, randomized, crossover design. Participants will therefore consume the 3 products (2 active products and 1 control).
(BASEC)
Intervento studiato
Comparator 1 Glycerol dose 1 and proteins
Comparator 2: Glycerol dose 2 and proteins
Placebo
(BASEC)
Malattie studiate
Dehydration
(BASEC)
1. Adult males and females aged 18 to 50 years. 2. Body Mass Index (BMI) between 18.5 and 25 kg/m² (inclusive). 3. In good health, as determined based on self-reported medical history. 4. Able to understand and sign a written informed consent before enrollment in the study. 5. Willing and able to comply with the requirements for participation in this study. (BASEC)
Criteri di esclusione
1. Any diagnosed past or current medical/surgical condition (e.g., malignancy, kidney disease, liver disease, uncontrolled diabetes, cardiovascular disease, hypertension, migraines, and head disorders) and/or psychiatric condition (e.g., depression, psychotic disorders, chronic insomnia, eating disorders), which, in the opinion of the site physician/investigator, could jeopardize the participant's well-being/safety, hinder the participant's compliance with study procedures or their ability to complete the study, and/or could confound the primary objectives of the study. 2. Current use of medications impacting hydration status (e.g., antihypertensive medications, antidiabetic medications, antipsychotics, antidepressants, diuretics, laxatives, antidiuretic hormone (ADH) antagonists, oral corticosteroids, glucocorticoids, anticholinergic medications, or cyclosporine A). 3. Currently following a high-protein diet (1.5 g/kg/BW/day) or a ketogenic diet. 4. Known/suspected food allergy or intolerance to any food (based on self-report). 5. Female participants who are pregnant, breastfeeding, and/or currently lactating (self-report or, in case of doubt, via a urine pregnancy test). 6. Any self-reported chronic alcohol or drug abuse in the past year; specifically, an average alcohol consumption of > 2 standard drinks per day over a week for men, and > 1 standard drink per day over a week for women. A standard drink contains 10-12 g of ethanol, which is 0.3 dl of spirits, 1 dl of wine, or 3 dl of beer. 7. Currently participating in another interventional study. 8. Family or hierarchical relationships with members of the research team. (BASEC)
Luogo dello studio
Losanna
(BASEC)
Sponsor
Société des Produits Nestlé SA
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Nora Schneider
+41 21 785 92 60
nora.schneider@clutterrdls.nestle.comClinical Research Unit, Clinical Innovation Lab
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
03.03.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
H2O – Hydration to be Optimized with a low-sodium beverage (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile