Sports Recovery Clinical Trial
Official title:
Alkaline Ionized Water: Sports Recovery and Inflammation Management
| Verified date | October 2016 |
| Source | Natural Immune Systems Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | June 2016 |
| Est. primary completion date | May 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 25 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - Male - Age 25-40 years (inclusive) - Body mass index (BMI) between 19.0 and 29.9 kg/m2 (inclusive) - Not regularly exercising or participating in team sports. Exclusion Criteria: - Bariatric surgery - Diagnosed and medicated for diabetes - Known serious chronic health condition - Serious active illness within past 12 months - Major surgery during past 8 weeks - Alcohol consumption of more than four standard units/day (for example more than four regular 12-oz beers (5% alcohol), four small 5-oz glasses of wine (12% alcohol), or four 1.5 oz shots of 80-proof spirits) (or more than 28 per week); - Regular use of marijuana products for the past three months - Regular consumption of energy drinks - Diagnosed with any blood clotting disorder or taking clotting factor concentrates. - Taking any blood thinners or anticoagulants - Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable) - Diagnosed with high blood pressure or taking blood pressure medication - Use of performance enhancing drugs within the last three months - Having consumed prednisone (or related steroid medication) or received a prednisone injection within the last six months |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | NIS Labs | Klamath Falls | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Natural Immune Systems Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Plasma lactate levels | Plasma lactate levels will be measured five times (at 15-minute intervals) within one hour after performing high intensity interval training exercise. | One hour | No |
| Secondary | Complete Blood Count | Complete blood count with differential will be performed immediately after, and at 1 hour after, performing high intensity interval training exercise. | One hour | No |