NCT02044679

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 19, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

January 22, 2014

Last Update Submit

September 15, 2016

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

  • Osmolality

    baseline

Study Arms (3)

A = Increase water intake 1

EXPERIMENTAL

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

Other: Water

B = Increase water intake 2

EXPERIMENTAL

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

Other: Water

C = no change

OTHER

No change

Other: No intervention

Interventions

WaterOTHER
A = Increase water intake 1B = Increase water intake 2
No interventionOTHER
C = no change

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BIOTRIAL

Rennes, 35042, France

Location

Related Publications (1)

  • 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.

    PMID: 28578535DERIVED

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2014

First Posted

January 24, 2014

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 19, 2016

Record last verified: 2016-09

Locations

FR(1)