A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health

This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Likert scale responses will be statistically compared from Baseline to each check-in. Participant responses and product feedback will be presented as percentage scores.

Study Overview

• Status: Completed
• Conditions: Constipation; Bloating; Gut Health; Bowel Movements
• 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:

• Be male or female. Be aged over 18. Have a BMI less than 35. Have issues with digestion, heartburn, indigestion, gas, or constipation. Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.

Be generally healthy - must not live with any uncontrolled disease.

Exclusion Criteria:

• Any person with a pre-existing chronic condition that might prevent the participant from adhering to the protocol, including any oncological and psychiatric disorders.

Anyone taking any prescribed medication targeting the gut. Anyone taking any supplements targeting the gut within the past month. Anyone with any 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 will follow this weekly dosing schedule: Week 1: Day 1-3: take 5 drops of ConcenTrace with 8oz of water or flavored water. Day 4-7: take 5 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 2: Take 10 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 3: Take 15 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Week 4: Take 20 drops of ConcenTrace 2x per day with 8 oz of water or flavored water. Weeks 5 - 12: Take 40 drops of ConcenTrace 1x per day 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 scores on the Gastrointestinal Symptom Rating Scale (GSRS). [Timeframe: Baseline to Week 12]	The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in stool consistency reported via the Bristol Stool Chart. [Timeframe: Baseline to Week 12]	The Bristol stool scale is a diagnostic medical tool designed to classify the form of human faeces into seven categories. Type 1 has spent the longest time in the bowel and type 7 the least time.	12 weeks
Changes in bowel movement frequency. [Timeframe: Baseline to Week 12]	The frequency that the participants have a bowel movement will be recorded via questionnaires.	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

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 20351

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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