Allgemeine Informationen
  • Krankheitskategorie Andere (BASEC)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Lausanne
    (BASEC)
  • Studienverantwortliche Dr. Nora Schneider nora.schneider@rdls.nestle.com (BASEC)
  • Datenquelle(n) BASEC: Import vom 13.06.2025 ICTRP: N/A
  • Letzte Aktualisierung 13.06.2025 15:15
HumRes66503 | SNCTP000006303 | BASEC2024-02444

H2O – Hydration to Optimize with a Low Sodium Beverage

  • Krankheitskategorie Andere (BASEC)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Lausanne
    (BASEC)
  • Studienverantwortliche Dr. Nora Schneider nora.schneider@rdls.nestle.com (BASEC)
  • Datenquelle(n) BASEC: Import vom 13.06.2025 ICTRP: N/A
  • Letzte Aktualisierung 13.06.2025 15:15

Zusammenfassung der Studie

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)

Untersuchte Intervention

Comparator 1 Glycerol dose 1 and proteins

Comparator 2: Glycerol dose 2 and proteins

Placebo

(BASEC)

Untersuchte Krankheit(en)

Dehydration

(BASEC)

Kriterien zur Teilnahme
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)

Ausschlusskriterien
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)

Studienstandort

Lausanne

(BASEC)

nicht verfügbar

Sponsor

Société des Produits Nestlé SA

(BASEC)

Kontakt für weitere Auskünfte zur Studie

Kontaktperson Schweiz

Dr. Nora Schneider

+41 21 785 92 60

nora.schneider@rdls.nestle.com

Clinical Research Unit, Clinical Innovation Lab

(BASEC)

Wissenschaftliche Auskünfte

nicht verfügbar

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Waadt

(BASEC)

Datum der Bewilligung durch die Ethikkommission

03.03.2025

(BASEC)


ICTRP Studien-ID
nicht verfügbar

Offizieller Titel (Genehmigt von der Ethikkommission)
H2O – Hydration to be Optimized with a low-sodium beverage (BASEC)

Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Registrierungsdatum
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Einschluss des ersten Teilnehmers
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Sekundäre Sponsoren
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Weitere Kontakte
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Sekundäre IDs
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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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Weitere Informationen zur Studie
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Ergebnisse der Studie

Zusammenfassung der Ergebnisse

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Link zu den Ergebnissen im Primärregister

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