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Aquamin and Prevention of Colon Cancer

NCT02647671 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-04-12

No results posted yet for this study

Summary

In the proposed study, investigators will conduct a 90-day dietary intervention study in human subjects. Thirty individuals at risk for adenomatous colon polyp formation will be randomized to receive a calcium and multi-mineral-rich natural product (Aquamin) or a comparable level of calcium alone. There will also be a placebo group. Prior to ingesting the study agents and following the course of treatment, colonic biopsies will be obtained by sigmoidoscopy and quantitatively examined for markers of growth and differentiation. In this study, metabolomic and microbial profiles will also be generated from fecal and colon mucosal samples taken at baseline and study endpoint.

Conditions

  • Colonic Cancer

Interventions

DRUG

Aquamin®

90 days of Aquamin

DRUG

Calcium Carbonate

90 days of Calcium Carbonate

DRUG

Placebo

90 days of placebo

Sponsors & Collaborators

  • James Varani

    lead OTHER

Principal Investigators

  • James Varani, PhD · University of Michigan

  • Muhammad N Aslam, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02647671 on ClinicalTrials.gov