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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02044679
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : September 19, 2016
Information provided by (Responsible Party):
Danone Research

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

Condition or disease Intervention/treatment Phase
Healthy Adults Other: Water Other: No intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: A = Increase water intake 1
+ 1,5 to 2,0 L/day of water
Other: Water
Experimental: B = Increase water intake 2
+ 1,0 to 1,5 L/day of water
Other: Water
C = no change
No change
Other: No intervention

Primary Outcome Measures :
  1. Osmolality [ Time Frame: baseline ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02044679

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Rennes, France, 35042
Sponsors and Collaborators
Danone Research
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Danone Research Identifier: NCT02044679    
Other Study ID Numbers: NU365
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016