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OpenTrials
Completed

NCT Number: NCT02044679

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

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

Completed

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Key information

Conditions

Healthy Adults

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BIOTRIAL

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Water

Other

No intervention

Other

Primary outcomes

  1. Osmolality

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Danone Global Research & Innovation Center

Industry

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 24, 2014
Registry last updated
Sep 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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