## Protocol Section
### Identification Module
**NCT ID:** NCT02044679

**Brief Title:** Evaluation of Spot Urine as a Biomarker of Fluid Intake in Real Life Conditions

#### Organization Study ID Info
**ID:** NU365
#### Organization
**Class:** INDUSTRY
**Full Name:** Danone Research
### Status Module
#### Completion Date
**Date:** 2014-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-09-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-09-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-03

**Type:** ACTUAL

#### Start Date
**Date:** 2013-10

**Status Verified Date:** 2016-09

#### Study First Post Date
**Date:** 2014-01-24
**Type:** ESTIMATED
**Study First Submit Date:** 2014-01-22
**Study First Submit QC Date:** 2014-01-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Danone Research

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

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

### Conditions Module

**Conditions:**

- Healthy Adults

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

#### Enrollment Info

**Count:** 82

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** + 1,5 to 2,0 L/day of water

**Intervention Names:**

- Other: Water

**Label:** A = Increase water intake 1

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** + 1,0 to 1,5 L/day of water

**Intervention Names:**

- Other: Water

**Label:** B = Increase water intake 2

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** No change

**Intervention Names:**

- Other: No intervention

**Label:** C = no change

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A = Increase water intake 1

- B = Increase water intake 2

**Name:** Water

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- C = no change

**Name:** No intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Osmolality

**Time Frame:** baseline

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 30 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rennes

**Country:** France

**Facility:** BIOTRIAL

**Zip:** 35042

### References Module

#### References

**Citation:** 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:** 28578535

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8219

- Name: Exanthema

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
