pHNCT06122597
A Clinical Trial to Evaluate the Efficacy of ConcenTrace to Buffer pH Levels Within the Body.
A study testing ConcenTrace in people with pH, run by Trace Minerals at 1 site in United States.
Trial summary
This virtual single-arm trial will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Urine pH measurements will be taken at Baseline, Week 4, Week 8, and Week 12 using pH test strips. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- pH
- What is being tested?
- ConcenTrace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 31 Jan 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female. Aged 18+. Generally healthy - don't live with any uncontrolled disease. Willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.
Who cannot join
- Anyone with a pre-existing chronic condition that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
This virtual single-arm trial will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12.
Urine pH measurements will be taken at Baseline, Week 4, Week 8, and Week 12 using pH test strips.
- Conditions
- pH
- Being tested
- ConcenTrace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcenTraceOther
The product contains concentrated seawater from Utah's inland sea.
| Study group | Role | What they receive |
|---|---|---|
| Test arm: ConcenTrace | Experimental | Participants should follow this weekly dosing schedule:
Week 1 - Days 1-3: take 5 drops of ConcenTrace with 8 oz of water or flavored water. Days 4-7: take 5 drops of ConcenTrace 2x daily with 8 oz of water or flavored water.
Week 2: Take 10 drops of ConcenTrace 2x daily with 8 oz of water or flavored water.
Week 3: Take 15 drops of ConcenTrace 2x daily with 8 oz of water or flavored water.
Weeks 4-12: Take 20 drops of ConcenTrace 2x daily with 8 oz of water or flavored water. Receives: Other: ConcenTrace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in urine pH levels. [Timeframe: Baseline to Week 12]
Participants will use pH test strips to measure urine pH. Changes in urine pH will be evaluated.
Measured: 12 weeks
Secondary outcomes (1)
Change in score on the Metabolic Screening Questionnaire.
A Metabolic Screening Questionnaire (MSQ) was developed by the Toronto Centre for Naturopathic Medicine. The symptoms represented on a MSQ represent symptoms commonly associated with inflammation and toxicity. Participants will rate frequency and intensity of applicable symptoms according to the following scores:
- Absent or rare symptoms - 0 points
- Occasional, mild symptoms - 1 point
- Occasional, severe symptoms - 2 points
- Frequent, mild symptoms - 3 points
- Frequent, severe symptoms - 4 points
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start5 Oct 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for pHStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trace Minerals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122597
- Sponsor's protocol ID
- 20352
- Status last verified
- Aug 2024
- First submitted
- 2 Nov 2023
- Last updated
- 23 Aug 2024
- 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 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy of ConcenTrace to Buffer pH Levels Within the Body.
- ClinicalTrials.gov ID
- NCT06122597
- Acronym / sponsor ID
- 20352
- Conditions
- pH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Trace MineralsIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 8 Nov 2023 (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.
This virtual single-arm trial will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12.
Urine pH measurements will be taken at Baseline, Week 4, Week 8, and Week 12 using pH test strips.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test arm: ConcenTrace | Experimental | Other: ConcenTraceParticipants should follow this weekly dosing schedule: Week 1 - Days 1-3: take 5 drops of ConcenTrace with 8 oz of water or flavored water. Days 4-7: take 5 drops of ConcenTrace 2x daily with 8 oz of water or flavored water. Week 2: Take 10 drops of ConcenTrace 2x daily with 8 oz of water or flavored water. Week 3: Take 15 drops of ConcenTrace 2x daily with 8 oz of water or flavored water. Weeks 4-12: Take 20 drops of ConcenTrace 2x daily with 8 oz of water or flavored water. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female. Aged 18+. Generally healthy - don't live with any uncontrolled disease. Willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.
Key exclusion criteria (2 listed)
- Anyone with a pre-existing chronic condition that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Anyone with known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.
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 |
|---|---|---|
| ConcenTraceThe product contains concentrated seawater from Utah's inland sea. | Other | Test arm: ConcenTrace |
Primary outcome
Changes in urine pH levels. [Timeframe: Baseline to Week 12]
Time frame: 12 weeks
Participants will use pH test strips to measure urine pH. Changes in urine pH will be evaluated.
1 secondary outcome
Change in score on the Metabolic Screening Questionnaire.
Time frame: 12 weeks
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 23 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ConcenTrace in people with pH, run by Trace Minerals 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 1 inclusion and 2 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 23 Aug 2024. 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. 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?
Changes in urine pH levels. [Timeframe: Baseline to Week 12] (time frame: 12 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 23 Aug 2024.