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

pH Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06122597
• Other study ID #: 20352
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: Trace Minerals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• pH

Intervention

Other:
• ConcenTrace
The product contains concentrated seawater from Utah's inland sea.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Trace Minerals	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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