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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alkaline water | Active Comparator | Participants will consume 1.5 liters per day |
|
| Reverse osmosis water | Placebo Comparator | Participants will consume 1.5 liters per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alkaline water | Dietary Supplement | 1.5 liters per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of hydration status using Bioelectrical Impedance Analysis | Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water. | Change from baseline to 2 weeks |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gitte Jensen, PhD | NIS Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601-5904 | United States |
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Randomized, double-blinded, placebo-controlled, cross-over trial
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| Reverse osmosis water |
| Dietary Supplement |
1.5 liters per day |
|