CompletedNCT02044679Updated Sep 19, 2016

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

An interventional study of Water and No intervention in Healthy Adults, sponsored by Danone Global Research & Innovation Center. Completed at 1 site in France. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-19.

Sponsored by Danone Global Research & Innovation Center · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 82
Allocation: Randomized
Ages: 20 Years to 30 Years
Sex: All

Study summary

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

Conditions studied

Healthy Adults

In context

Lead sponsor

Danone Global Research & Innovation Center is the lead sponsor of 38 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 30 Years
Sexes eligible: 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

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

Phase: Not applicable
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 82 participants (actual)

Study arms

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
Other
C = no change
No change
Other: No intervention

Interventions

OtherWater
OtherNo intervention

What researchers measure

Primary outcomes

Osmolality
Time frame: baseline

Study locations

1 site

BIOTRIAL
Rennes, 35042, France

References and documents

Publications

Lemetais G, Melander O, Vecchio M, Bottin JH, Enhorning S, Perrier ET. Effect of increased water intake on plasma copeptin in healthy adults. Eur J Nutr. 2018 Aug;57(5):1883-1890. doi: 10.1007/s00394-017-1471-6. Epub 2017 Jun 3. PubMed 28578535 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02044679
Lead sponsor: Danone Global Research & Innovation Center
Responsible party: Sponsor
First posted: Jan 24, 2014
Start date: Oct 2013
Primary completion: Mar 2014
Completion: Mar 2014
Last update: Sep 19, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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