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Effects of Mentholated Popsicle on vasopressin, thirst and discomfort

Effects of Mentholated Popsicle on vasopressin, osmolarity, intensity, thirst discomfort and oral dehydration: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4gxbszn
Enrollment
Unknown
Registered
2022-08-24
Start date
2021-04-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arginine Vasopressin

Interventions

This is a two-arm, open-label, randomized clinical trial. Randomized clinical trial carried out in a clinical analysis laboratory in northern Paraná. The study will include 40 healthy volunteers (20 v
VS2.001.001.002.002
B01.875.800.575.912.250.583.520.483

Sponsors

Universidade Estadual de Londrina
Lead Sponsor
Universidade Estadual de Londrina
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 50 years; male, not be smoker; not be alcoholic; daily fluid intake habits: minimum of 2 liters of water / day

Exclusion criteria

Exclusion criteria: Kidney failure; systemic arterial hypertension; diabetes; hydroelectrolytic disorders such as vomiting and diarrhea; women

Design outcomes

Primary

MeasureTime frame
To assess the efficacy of the mentholated popsicle compared to usual care in healthy volunteers, about the plasma vasopressin. A randomized clinical trial, in parallel, with two groups: control group and experimental group. It will be considered the level if significance of 5% and confidence interval of 95%. To test the effect of mentholated popsicles ANOVA will be used according to the multivariate model. It is expected to observe a reduction profile vasopressin when receiving mentholated popsicle.

Secondary

MeasureTime frame
Compare plasma vasopressin, osmolarity, intensity, discomfort of thirst and oral dehydration, after receiving the mentholated popsicle in relation to usual care. A randomized clinical trial, in parallel, with two groups: control group and experimental group. It will be considered the level if significance of 5% and confidence interval of 95%. The normality distribution of the urinary osmolarity variable will be determined by the Shapiro-Wilk test, later it will be evaluated using the Student's t test. To test the effect of mentholated popsicles in the five on intensity, discomfort, concentration of osmolarity and intramural oral moisture, one-way ANOVA will be used according to the multivariate model. It is expected to observe a reduction in the intensity and discomfort of thirst, as well as an improvement in oral intramucosal moisture.

Countries

Brazil

Contacts

Public ContactThammy Nakaya

Universidade Estadual de Londrina

thammynakaya@hotmail.com+55 (43) 99604-7036

Outcome results

None listed

Source: REBEC (via WHO ICTRP)