H2O – Hydration to Optimize with a Low Sodium Beverage
Résumé de l'étude
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)
Intervention étudiée
Comparator 1 Glycerol dose 1 and proteins
Comparator 2: Glycerol dose 2 and proteins
Placebo
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
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)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
Société des Produits Nestlé SA
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. Nora Schneider
+41 21 785 92 60
nora.schneider@clutterrdls.nestle.comClinical Research Unit, Clinical Innovation Lab
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
03.03.2025
(BASEC)
Identifiant de l'essai ICTRP
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Titre officiel (approuvé par le comité d'éthique)
H2O – Hydration to be Optimized with a low-sodium beverage (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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