A Clinical Trial to Evaluate the Efficacy of ConcenTrace to Buffer pH Levels Within the Body.

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Trial to Evaluate the Efficacy of ConcenTrace to Buffer pH Levels Within the Body.

Conditions
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pH

Intervention / Treatment
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* Other: ConcenTrace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test arm: ConcenTrace<br>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. | Other: ConcenTrace<br>* The product contains concentrated seawater from Utah's inland sea.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks |