Water Deprivation Protocol

NCT01224704 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

\- One area in which obese and lean individuals may be different is how their bodies handle water balance and thirst. Studies done in animals suggest that individuals with greater body fat may tolerate periods without water better than lean animals. Other research has found a link between the ability to tolerate periods without water and increased body weight. Researchers are interested in studying whether the ability to tolerate periods without water and ability to feel thirst might differ in lean versus obese individuals.

Objectives:

\- To evaluate the effects of water deprivation and feelings of thirst in lean and obese individuals.

Eligibility:

\- Healthy individuals at least 18 years of age who are either lean (body mass index less than 26 kg/m(2)) or obese (body mass index at least 35 kg/m(2)).

Design:

* Participants will be screened with a medical history, physical examination, and blood and urine tests.
* Participants will spend the entire study (13 days) as inpatients at the National Institutes of Health Clinical Center.
* Participants will have the following tests and procedures:
* Body composition assessment (using low-level x-rays) to determine the percentage of fat tissue in the body.
* Oral glucose tolerance test (similar to that often used to diagnose diabetes). Individuals who are suspected to have diabetes will not be allowed to continue with the study.
* High salt infusion test, in which an infusion of saline (salt water) will be given for 2 hours and participants will respond to questions about how hungry and thirsty they feel during the procedure.
* Water deprivation test, in which participants will go for 24 hours without water or food and respond to questions about how hungry and thirsty they feel.
* 24-hour stay in a metabolic chamber to determine how many calories participants burn in a day.
* A series of questionnaires about participants' eating habits, feelings about food, and personal feelings, as well as computer-based tests involving the performance of various tasks.
* Measurement of free-living energy using doubly-labeled water, in which participants will drink a sample of water with extra-heavy atoms of hydrogen and oxygen to evaluate the amount of water in the body.
* 24-hour urine collection.
* Frequent blood samples, urine collection, and fat tissue biopsies during the various study procedures.
* After the end of the 13-day study, participants will return after 1 week for a final urine collection.

Conditions

Interventions

OTHER

Hypertonic saline infusion

Three percent saline (0.1ml/kg of the lean mass/min) will be infused for 120 minutes.

OTHER

Water deprivation

24 hour water deprivation

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Marci E Gluck, Ph.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-19
Primary Completion
2018-09-09
Completion
2019-03-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01224704 on ClinicalTrials.gov