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

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 Overview

• Status: Completed
• Conditions: pH
• Intervention / Treatment: Other: ConcenTrace

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Trace Minerals
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20352

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No