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

NCT06122571 | Completed

• 1 other identifier: 20351
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gut Health; Bowel Movements; Constipation; Bloating

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in stool consistency reported via the Bristol Stool Chart. [Timeframe: Baseline to Week 12]

  12 weeks

• Changes in bowel movement frequency. [Timeframe: Baseline to Week 12]

  12 weeks

Study Arms (1)

Test arm: ConcenTrace

EXPERIMENTAL

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

Interventions

ConcenTrace OTHER

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

Test arm: ConcenTrace

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trace Minerals: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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)