Alkaline Ionized Water: Sports Recovery and Inflammation Management
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedNovember 1, 2016
October 1, 2016
2 months
March 11, 2016
October 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Complete Blood Count
One hour
Study Arms (2)
Tap water
PLACEBO COMPARATOROral consumption of tap water
Alkaline ionized water
ACTIVE COMPARATOROral consumption of alkaline ionized water
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NIS Labs
Klamath Falls, Oregon, 97601, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Gitte S Jensen, PhD
Natural Immune Systems Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
March 11, 2016
First Posted
April 22, 2016
Study Start
March 1, 2016
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
November 1, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will not share