Biomarkers for Noninvasive Assessment of Human Hydration

NCT01507129 | Completed DMC

• 1 other identifier: DM102745
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Low levels of dehydration (the loss of body water corresponding to 2% of the body weight), deteriorate physical and cognitive performance and may also be linked to a number of chronic diseases. The standard test used for the assessment of hydration status is plasma osmolality. This blood test is invasive, requires time and laboratory equipment and is not accurate for isotonic dehydration. The goal of this project is to determine whether a new molecular technology, saliva-based Stress Response Profiling (SRP) biomarkers, could be used for non-invasive diagnostics of dehydration.

Conditions

Dehydration

Keywords

dehydration; plasma; osmolality; saliva; urine; biomarkers; hypertonic; isotonic; hydration

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Aerobically fit individuals

You may qualify if:

• Signed Informed Consent Form
• Males and females between 18-40, healthy and aerobically fit determined by VO2max test. Minimum 45 ml/kg/min for males and 40 ml/kg/min for females
• Willing to stop drinking any alcoholic beverages, taking all supplements and limit medications to those approved for the study
• No heart conditions assessed by medical history and passing the PAR-Q
• Complete and pass medical exam

You may not qualify if:

• Positive response to any PAR-Q questions
• Physical problems/injuries associated with walking or cycling
• VO2Max below 45 ml/kg/min for men and 40 ml/kg/min for women
• Allergy to sulfa drugs
• Existing heart and or lung conditions
• Pregnant or breastfeeding
• History of heat illness or heat injury
• History of kidney stones or chronic renal problems
• History of orthostatic hypotension, diabetes or gout
• Taking certain medications: NSAIDS \[anti-inflammatory/pain medications\], digitalis \[a type of heart medication\], lithium and anti-depressants \[medications used in psychiatry\], anti-hypertensives \[medications to lower the blood pressure\], anti-fungals \[medications used to treat infectious type of mold\], supplements or anti-cholinergic drugs)
• Taking any supplements, particularly creatine in 24 hours before the start of the study, or during the study
• Alcohol consumption 24 hours before the start of the study, or during the study
• Incapable to give informed consent
• Anemia

Sponsors & Collaborators

• Gaia Medical Institute: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Clinical and Translational Research Institute

San Diego, California, 92037, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, Urine, Saliva

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter D Wagner, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Sarka Southern, Ph.D.

  Gaia Medical Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

US (1)