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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-05

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gut Health Bowel Movements Constipation Bloating

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ConcenTrace

Intervention Type OTHER

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

Interventions

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ConcenTrace

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes