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

• Sponsor: Trace Minerals (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06122597
• Collaborator: Citruslabs (Industry)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
pH	Other: ConcenTrace	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Clinical Trial to Evaluate the Efficacy of ConcenTrace to Buffer pH Levels Within the Body.
• Actual Study Start Date: Oct 5, 2023
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Test arm: ConcenTrace 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; The product contains concentrated seawater from Utah's inland sea.

Outcome Measures

Primary Outcome Measures

1. Changes in urine pH levels. [Timeframe: Baseline to Week 12] [12 weeks]

   Participants will use pH test strips to measure urine pH. Changes in urine pH will be evaluated.

Secondary Outcome Measures

1. Change in score on the Metabolic Screening Questionnaire. [12 weeks]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

• Trace Minerals
• Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Trace Minerals
• ClinicalTrials.gov Identifier: NCT06122597
• Other Study ID Numbers: 20352
• First Posted: Nov 8, 2023
• Last Update Posted: Nov 8, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 8, 2023