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Alkaline Ionized Water: Sports Recovery and Inflammation Management

Primary Purpose

Sports Recovery

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alkaline ionized water
Tap water
Sponsored by
Natural Immune Systems Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sports Recovery

Eligibility Criteria

25 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • NIS Labs

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Tap water

Alkaline ionized water

Arm Description

Oral consumption of tap water

Oral consumption of alkaline ionized water

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Complete Blood Count
Complete blood count with differential will be performed immediately after, and at 1 hour after, performing high intensity interval training exercise.

Full Information

First Posted
March 11, 2016
Last Updated
October 31, 2016
Sponsor
Natural Immune Systems Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02748655
Brief Title
Alkaline Ionized Water: Sports Recovery and Inflammation Management
Official Title
Alkaline Ionized Water: Sports Recovery and Inflammation Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Natural Immune Systems Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery.
Detailed Description
Alkaline ionized water versus tap water is consumed for one week prior to an exercise challenge, using a cross-over study design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Recovery

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tap water
Arm Type
Placebo Comparator
Arm Description
Oral consumption of tap water
Arm Title
Alkaline ionized water
Arm Type
Active Comparator
Arm Description
Oral consumption of alkaline ionized water
Intervention Type
Other
Intervention Name(s)
Alkaline ionized water
Intervention Type
Other
Intervention Name(s)
Tap water
Primary Outcome Measure Information:
Title
Plasma lactate levels
Description
Plasma lactate levels will be measured five times (at 15-minute intervals) within one hour after performing high intensity interval training exercise.
Time Frame
One hour
Secondary Outcome Measure Information:
Title
Complete Blood Count
Description
Complete blood count with differential will be performed immediately after, and at 1 hour after, performing high intensity interval training exercise.
Time Frame
One hour

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gitte S Jensen, PhD
Organizational Affiliation
Natural Immune Systems Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
NIS Labs
City
Klamath Falls
State/Province
Oregon
ZIP/Postal Code
97601
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Alkaline Ionized Water: Sports Recovery and Inflammation Management

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