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

NCT ID: NCT02044679

Last Updated: 2016-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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A = Increase water intake 1

\+ 1,5 to 2,0 L/day of water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

B = Increase water intake 2

\+ 1,0 to 1,5 L/day of water

Group Type EXPERIMENTAL

Water

Intervention Type OTHER

C = no change

No change

Group Type OTHER

No intervention

Intervention Type OTHER

Interventions

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Water

Intervention Type OTHER

No intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danone Global Research & Innovation Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BIOTRIAL

Rennes, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 28578535 (View on PubMed)

Other Identifiers

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NU365

Identifier Type: -

Identifier Source: org_study_id

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