Dehydration Clinical Trial
Official title:
Biomarkers for Noninvasive Assessment of Human Hydration
Verified date | August 2012 |
Source | Gaia Medical Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Observational Model: Case-Only, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | Clinical and Translational Research Institute | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Gaia Medical Institute | U.S. Army Medical Research and Materiel Command |
United States,
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