HydrationNCT04460846
Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water.
A study testing Alkaline water and Reverse osmosis water in people with Hydration, run by Natural Immune Systems Inc at 1 site in United States.
Trial summary
To conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population of chronically, moderately dehydrated people comparing two waters on hydration status. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hydration
- What is being tested?
- Alkaline water and Reverse osmosis water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 19 Dec 2021
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult people of either gender;
- Age 18 - 65 years (inclusive);
- BMI between 18.0 and 34.9 (inclusive);
- Screening results showing at least one of the following:
- Hematocrit: Women: 45.0 or higher; Men: 48.7 or higher;
- BUN/Creatinine ratio 20 or higher;
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- Sodium levels 146 mmol/L or higher;
- Potassium levels 5.3 mmol/L or higher;
- Chloride levels 108 mmol/L or higher.
- Willing to maintain a consistent diet (including medications, vitamins and supplements) and lifestyle routine throughout the study;
- Willing to abstain from coffee, tea, soft drinks, and nicotine for at least one hour prior to a clinic visit;
- Willing to abstain from alcohol for at least 12 hours prior to a clinic visit;
- Willing to maintain a consistent habit of abstaining from exercising and nutritional supplements on the morning of a study visit.
Who cannot join
- Cancer during past 12 months;
- Chemotherapy during past 12 months;
- Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
- Previous major surgery to stomach or intestines [(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal];
- Implanted electronic device such as pacemaker or implantable cardioverter-defibrillator (ICD);
- Currently experiencing peripheral edema in legs and /or feet;
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- Diagnosed with any blood clotting disorder or taking clotting factor concentrates;
- Diagnosis of Peripheral Artery Disease;
- Diagnosis of varicose veins;
- Currently taking blood pressure medication;
- Currently taking blood thinning medication (81mg aspirin allowed);
- Currently taking diuretic medication;
- Currently taking nutritional supplements and other substances judged by the study coordinator to negate or camouflage the effects of the test product;
- Women who are pregnant, nursing, or trying to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water: A Randomized Controlled Cross-over Pilot Study
To conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population of chronically, moderately dehydrated people comparing two waters on hydration status.
Read the detailed description
A randomized, double-blinded, placebo-controlled cross-over study design will be used to evaluate the effects of consumption of alkaline water against reverse osmosis water. The study is of 5 weeks' duration, with evaluation at baseline, 2 weeks (beginning of wash-out period), 3 weeks (end of wash-out period), and 5 weeks.
- Conditions
- Hydration
- Being tested
- Alkaline water, Reverse osmosis water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alkaline waterDietary supplement
1.5 liters per day
Reverse osmosis waterDietary supplement
1.5 liters per day
| Study group | Role | What they receive |
|---|---|---|
| Alkaline water | Active comparator | Participants will consume 1.5 liters per day Receives: Dietary Supplement: Alkaline water |
| Reverse osmosis water | Placebo comparator | Participants will consume 1.5 liters per day Receives: Dietary Supplement: Reverse osmosis water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of hydration status using Bioelectrical Impedance Analysis
Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water.
Measured: Change from baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Mar 2020
- Primary completion25 Nov 2021
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, placebo-controlled, cross-over trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gitte Jensen, PhD, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460846
- Sponsor's protocol ID
- NIS165-003
- Status last verified
- Jun 2022
- First submitted
- 11 Mar 2020
- Last updated
- 27 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water: A Randomized Controlled Cross-over Pilot Study
- ClinicalTrials.gov ID
- NCT04460846
- Acronym / sponsor ID
- NIS165-003
- Conditions
- Hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 8 Jul 2020 (actual)
- 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.
To conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population of chronically, moderately dehydrated people comparing two waters on hydration status.
Detailed description
A randomized, double-blinded, placebo-controlled cross-over study design will be used to evaluate the effects of consumption of alkaline water against reverse osmosis water. The study is of 5 weeks' duration, with evaluation at baseline, 2 weeks (beginning of wash-out period), 3 weeks (end of wash-out period), and 5 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Alkaline water | Active comparator | Dietary Supplement: Alkaline waterParticipants will consume 1.5 liters per day |
| Reverse osmosis water | Placebo comparator | Dietary Supplement: Reverse osmosis waterParticipants will consume 1.5 liters per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult people of either gender;
- Age 18 - 65 years (inclusive);
- BMI between 18.0 and 34.9 (inclusive);
- Screening results showing at least one of the following:
- Willing to maintain a consistent diet (including medications, vitamins and supplements) and lifestyle routine throughout the study;
Key exclusion criteria (14 listed)
- Cancer during past 12 months;
- Chemotherapy during past 12 months;
- Significant active uncontrolled illness (such as lymphoma, liver disease, kidney failure, heart failure).
- Previous major surgery to stomach or intestines [(absorption of test product may be altered) minor surgery is not a problem, including appendix and gallbladder removal];
- Implanted electronic device such as pacemaker or implantable cardioverter-defibrillator (ICD);
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 water1.5 liters per day | Dietary supplement | Alkaline water |
| Reverse osmosis water1.5 liters per day | Dietary supplement | Reverse osmosis water |
Primary outcome
Evaluation of hydration status using Bioelectrical Impedance Analysis
Time frame: Change from baseline to 2 weeks
Bioelectrical Impedance Analysis performed using an RJL system, capturing information on intracellular and extracellular water.
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 27 Sep 2022.
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Hydration Status
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 Jensen, PhD principal investigator
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alkaline water and Reverse osmosis water in people with Hydration, 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 13 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 27 Sep 2022. 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.
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?
Evaluation of hydration status using Bioelectrical Impedance Analysis (time frame: Change from baseline to 2 weeks). 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 27 Sep 2022.