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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Adults | Other: Water Other: No intervention | Not Applicable |
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 |
- Osmolality [ Time Frame: baseline ]

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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.

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
France | |
BIOTRIAL | |
Rennes, France, 35042 |
Responsible Party: | Danone Research |
ClinicalTrials.gov 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 |