Alkaline Ionized Water: Sports Recovery and Inflammation Management

NCT ID: NCT02748655

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery.

Detailed Description

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Alkaline ionized water versus tap water is consumed for one week prior to an exercise challenge, using a cross-over study design.

Conditions

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Sports Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tap water

Oral consumption of tap water

Group Type PLACEBO_COMPARATOR

Tap water

Intervention Type OTHER

Alkaline ionized water

Oral consumption of alkaline ionized water

Group Type ACTIVE_COMPARATOR

Alkaline ionized water

Intervention Type OTHER

Interventions

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Alkaline ionized water

Intervention Type OTHER

Tap water

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Immune Systems Inc

OTHER

Sponsor Role lead

Responsible Party

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Gitte Jensen, Ph.D.

Research Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gitte S Jensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Natural Immune Systems Inc

Locations

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NIS Labs

Klamath Falls, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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NIS119004

Identifier Type: -

Identifier Source: org_study_id