Water Deprivation Protocol

NCT01224704 | Completed

• 2 other identifiers: 99991100811-DK-N008
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

Hypertonic Saline Infusion; Water Deprivation; Thirst; Water/Electrolytes Homeostasis; Obesity

Outcome Measures

Primary Outcomes (1)

• Water intake

  Water intake (ml/kg body weight) over the first hour following water deprivation or saline infusion

  End of 24 hour intervention

Secondary Outcomes (2)

• Hormonal response

  During and at the end of intervention

• Thirst rating

  During and at the end of interventions

Study Arms (4)

Lean: hypertonic first

EXPERIMENTAL

Lean: Hypertonic solution at day 6 and water deprivation at day 10

Other: Hypertonic saline infusion; Other: Water deprivation

Lean: water deprivation first

EXPERIMENTAL

Lean: Water deprivation at day 6 and hypertonic solution at day 10

Other: Hypertonic saline infusion; Other: Water deprivation

Obese: hypertonic first

EXPERIMENTAL

Obese: Hypertonic solution at day 6 and water deprivation at day 10

Other: Hypertonic saline infusion; Other: Water deprivation

Obese: water deprivation first

EXPERIMENTAL

Obese: Water deprivation at day 6 and hypertonic solution at day 10

Other: Hypertonic saline infusion; Other: Water deprivation

Interventions

Water deprivation OTHER

24 hour water deprivation

Lean: hypertonic first; Lean: water deprivation first; Obese: hypertonic first; Obese: water deprivation first

Hypertonic saline infusion OTHER

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

Lean: hypertonic first; Lean: water deprivation first; Obese: hypertonic first; Obese: water deprivation first

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male.
• Age 18-50 yrs to minimize hormonal influences on thirst perception in aging men.
• BMI\<25 kg/m\^2 for the lean group and BMI \>=35 kg/m\^2 for obese group (but weigh less than 350 pounds to accommodate the DXA scanner) for the obese group.

You may not qualify if:

• History or Clinical Manifestation of:
• Currently smoking
• Any medications
• Weight \<50kg (as the blood withdrawal limit would be exceeded)
• Hemoglobin concentration \< 12mg/dl on screening labs
• Type 1 or type 2 diabetes (according to World Health Organization diagnostic criteria (59))
• Endocrine disorders (Cushing's disease, pituitary diseases, hypo- or hyperthyroidism, diabetes insipidus, SIADH)
• Hypertension as diagnosed and treated by an outside physician or by sitting blood pressure measurement, using an appropriate cuff, \>140/90 mmHg on two or more occasions
• Fasting triglyceride concentrations \>= 500 mg/dl
• Cardiovascular disease, including coronary heart disease, heart failure, arrhythmias and peripheral arterial disease
• Liver disease, including cirrhosis, active hepatitis B or C and AST or ALT \>= 3x normal
• Renal disease, as defined by serum creatinine concentrations \>= 1.5 mg/dl and / or proteinuria \>300 mg/day (200 (micro)g/min)
• Central nervous system disease, including previous history of cerebrovascular accidents, dementia, and neurodegenerative disorders
• Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have been clearly cured or, in the opinion of the investigator, carry an excellent prognosis
• Infectious diseases such as active tuberculosis, HIV (by self report), chronic coccidioidomycoses or other chronic infections

Sponsors & Collaborators

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

Study Sites (1)

NIDDK, Phoenix

Phoenix, Arizona, 85014, United States

Location

Related Publications (5)

• Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.

  PMID: 16595758 BACKGROUND

• Esslinger KA, Jones PJ. Dietary sodium intake and mortality. Nutr Rev. 1998 Oct;56(10):311-3. doi: 10.1111/j.1753-4887.1998.tb01667.x.

  PMID: 9810812 BACKGROUND

• Cohen HW, Hailpern SM, Fang J, Alderman MH. Sodium intake and mortality in the NHANES II follow-up study. Am J Med. 2006 Mar;119(3):275.e7-14. doi: 10.1016/j.amjmed.2005.10.042.

  PMID: 16490476 BACKGROUND

• Stinson EJ, Graham AL, Thearle MS, Gluck ME, Krakoff J, Piaggi P. Cognitive dietary restraint, disinhibition, and hunger are associated with 24-h energy expenditure. Int J Obes (Lond). 2019 Jul;43(7):1456-1465. doi: 10.1038/s41366-018-0305-9. Epub 2019 Jan 16.

  PMID: 30651576 DERIVED

• Stinson EJ, Krakoff J, Gluck ME. Depressive symptoms and poorer performance on the Stroop Task are associated with weight gain. Physiol Behav. 2018 Mar 15;186:25-30. doi: 10.1016/j.physbeh.2018.01.005. Epub 2018 Jan 9.

  PMID: 29326031 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marci E Gluck, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2010
• First Posted: October 20, 2010
• Study Start: October 19, 2010
• Primary Completion: September 9, 2018
• Study Completion: March 28, 2019
• Last Updated: April 20, 2026

Record last verified: 2026-03-24

Locations

US (1)