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

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ClinicalTrials.gov Identifier: NCT02044679
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Danone Research

Study Description
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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

Study Design
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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
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT02044679


Locations
France
BIOTRIAL
Rennes, France, 35042
Sponsors and Collaborators
Danone Research
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Danone Research
ClinicalTrials.gov Identifier: NCT02044679     History of Changes
Other Study ID Numbers: NU365
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016