Hydration
Conditions
Brief summary
To conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population of chronically, moderately dehydrated people comparing two waters on hydration status.
Detailed description
A randomized, double-blinded, placebo-controlled cross-over study design will be used to evaluate the effects of consumption of alkaline water against reverse osmosis water. The study is of 5 weeks' duration, with evaluation at baseline, 2 weeks (beginning of wash-out period), 3 weeks (end of wash-out period), and 5 weeks.
Interventions
DIETARY_SUPPLEMENTAlkaline water
1.5 liters per day
DIETARY_SUPPLEMENTReverse osmosis water
1.5 liters per day
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Intervention model description
Randomized, double-blinded, placebo-controlled, cross-over trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult people of either gender; * Age 18 - 65 years (inclusive); * BMI between 18.0 and 34.9 (inclusive); * Screening results showing at least one of the following: * Hematocrit: Women: 45.0 or higher; Men: 48.7 or higher; * BUN/Creatinine ratio 20 or higher; * Sodium levels 146 mmol/L or higher; * Potassium levels 5.3 mmol/L or higher; * Chloride levels 108 mmol/L or higher. * Willing to maintain a consistent diet (including medications, vitamins and supplements) and lifestyle routine throughout the study; * Willing to abstain from coffee, tea, soft drinks, and nicotine for at least one hour prior to a clinic visit; * Willing to abstain from alcohol for at least 12 hours prior to a clinic visit; * Willing to maintain a consistent habit of abstaining from exercising and nutritional supplements on the morning of a study visit.
Exclusion criteria
* Cancer during past 12 months; * Chemotherapy during past 12 months; * Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure). * Previous major surgery to stomach or intestines \[(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal\]; * Implanted electronic device such as pacemaker or implantable cardioverter-defibrillator (ICD); * Currently experiencing peripheral edema in legs and /or feet; * Diagnosed with any blood clotting disorder or taking clotting factor concentrates; * Diagnosis of Peripheral Artery Disease; * Diagnosis of varicose veins; * Currently taking blood pressure medication; * Currently taking blood thinning medication (81mg aspirin allowed); * Currently taking diuretic medication; * Currently taking nutritional supplements and other substances judged by the study coordinator to negate or camouflage the effects of the test product; * Women who are pregnant, nursing, or trying to become pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of hydration status using Bioelectrical Impedance Analysis | Change from baseline to 2 weeks | Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water. |
Countries
United States
Outcome results
None listed