Sports RecoveryPhase 1/2NCT02748655
Alkaline Ionized Water: Sports Recovery and Inflammation Management
A Phase 1/2 study testing Alkaline ionized water and Tap water in people with Sports Recovery, run by Natural Immune Systems Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery. Read more about this study
- Who is it for?
- Ages 25 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sports Recovery
- What is being tested?
- Alkaline ionized water and Tap water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jun 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery.
Read the detailed description
Alkaline ionized water versus tap water is consumed for one week prior to an exercise challenge, using a cross-over study design.
- Conditions
- Sports Recovery
- Being tested
- Alkaline ionized water, Tap water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkaline ionized waterOther
Tap waterOther
| Study group | Role | What they receive |
|---|---|---|
| Tap water | Placebo comparator | Oral consumption of tap water Receives: Other: Tap water |
| Alkaline ionized water | Active comparator | Oral consumption of alkaline ionized water Receives: Other: Alkaline ionized water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One hour
Secondary outcomes (1)
Complete Blood Count
Complete blood count with differential will be performed immediately after, and at 1 hour after, performing high intensity interval training exercise.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Jensen, Ph.D., Natural Immune Systems Inc
- Investigators
- Gitte S Jensen, PhD, Principal investigator, Natural Immune Systems Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748655
- Sponsor's protocol ID
- NIS119004
- Status last verified
- Oct 2016
- First submitted
- 11 Mar 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alkaline Ionized Water: Sports Recovery and Inflammation Management
- ClinicalTrials.gov ID
- NCT02748655
- Acronym / sponsor ID
- NIS119004
- Conditions
- Sports Recovery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tap water | Placebo comparator | Other: Tap waterOral consumption of tap water |
| Alkaline ionized water | Active comparator | Other: Alkaline ionized waterOral consumption of alkaline ionized water |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alkaline ionized water | Other | Alkaline ionized water |
| Tap water | Other | Tap water |
Primary outcome
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.
1 secondary outcome
Complete Blood Count
Time frame: One hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitte S Jensen, PhD principal investigator
Natural Immune Systems Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Alkaline ionized water and Tap water in people with Sports Recovery, run by Natural Immune Systems Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma lactate levels (time frame: One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.