NCT06122597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

November 2, 2023

Last Update Submit

August 21, 2024

Conditions

pH

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in score on the Metabolic Screening Questionnaire.

    12 weeks

Study Arms (1)

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.

Other: ConcenTrace

Interventions

ConcenTraceOTHER

The product contains concentrated seawater from Utah's inland sea.

Test arm: ConcenTrace

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 8, 2023

Study Start

October 5, 2023

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

August 23, 2024

Record last verified: 2024-08

Locations

US(1)