Alkaline Ionized Water: Sports Recovery and Inflammation Management

October 31, 2016 updated by: Gitte Jensen, Ph.D., Natural Immune Systems Inc
The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Klamath Falls, Oregon, United States, 97601
        • NIS Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Tap water
Oral consumption of tap water
Other: Tap water
Active Comparator: Alkaline ionized water
Oral consumption of alkaline ionized water
Other: Alkaline ionized water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma lactate levels
Time Frame: One hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Blood Count
Time Frame: One hour
Complete blood count with differential will be performed immediately after, and at 1 hour after, performing high intensity interval training exercise.
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Natural Immune Systems Inc

Investigators

  • Principal Investigator: Gitte S Jensen, PhD, Natural Immune Systems Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

April 21, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Estimate)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 31, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS119004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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