Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions

Healthy Adults Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02044679
• Other study ID #: NU365
• Status: Completed
• Phase: N/A
• First received: January 22, 2014
• Last updated: September 15, 2016
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2016
• Source: Danone Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Evaluate urine osmolality as a marker of fluid intake, in healthy subjects displaying a wide range of fluid intake behaviors

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy female and male subjects aged 20- 30 years old (both ages included).

• BMI within the range 20-25 kg/m2 (both inclusive).

• Height within the range 1.60-1.75 m (both inclusive) for female subjects and 1.70-1.85 m (both inclusive) for male subjects.

• Monophasic contraceptive method (female subjects only)

• Smoking less than 10 cigarettes/day

• Fluid intake habits falling within one of three designated arms

Exclusion Criteria:

• Pregnant woman (as determined by a pregnancy test) or woman planning to become pregnant during the study; breast-feeding woman.

• Any clinically relevant acute or chronic diseases which could interfere with the subjects' safety during the trial, or expose them to undue risk, or which could interfere with the study objectives.

• Having participated in a clinical study for the renal diseases or having received any treatment related to the kidneys, cardiovascular disease or to hypertension in the last 12 months.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Other:
• Water

• No intervention

Locations

Country	Name	City	State
France	BIOTRIAL	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Danone Research

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osmolality		baseline	No