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Aquamin and Prevention of Colon Cancer

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ClinicalTrials.gov Identifier: NCT02647671
Recruitment Status : Active, not recruiting
First Posted : January 6, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
James Varani, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Colonic Cancer Drug: Aquamin® Drug: Calcium Carbonate Drug: Placebo Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effects of Calcium in Conjunction With Multi-mineral Supplementation (Aquamin) on Gut Microbes and Microbially-derived Metabolites in Subjects at Risk for Colon Cancer in a Randomized Controlled Trial
Actual Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Aquamin®
Experimental: Aquamin® (4 capsules per day) - 4 capsules; 2 to be taken in the morning and 2 in the evening
Drug: Aquamin®
90 days of Aquamin

Active Comparator: Calcium Carbonate
Active Comparator: Calcium Carbonate (4 capsules per day) - 4 capsules; 2 to be taken in the morning and 2 in the evening
Drug: Calcium Carbonate
90 days of Calcium Carbonate

Placebo Comparator: Placebo
Placebo (Maltodextrin) - 4 capsules; 2 to be taken in the morning and 2 in the evening
Drug: Placebo
90 days of placebo
Other Name: Maltodextrin




Primary Outcome Measures :
  1. Biomarkers of Risk for Colorectal Cancer [ Time Frame: 90 days ]
    A panel of biomarkers of risk for colorectal cancer in colonic mucosal biopsies of normal appearing tissue: proliferation marker (Ki67), differentiation markers (E-cadherin, AE1/AE3 and cytokeratin [CK 20]), β-catenin, extracellular calcium-sensing receptor (CaSR), Caspase-3, bax and survivin assessed by quantitative immunohistology. The purpose is to compare growth, differentiation and apoptosis biomarkers, pre and post intervention.

  2. Colonic-mucosal Associated Microbial Profile. [ Time Frame: 90 days ]
    In colonic mucosa and stool samples: Microbial analysis will be performed on colonic mucosa and stool samples. This analysis will show the difference in microbial communities before and after the intervention.

  3. Colonic-mucosal Associated Metabolomic Profile. [ Time Frame: 90 days ]
    In serum, colonic mucosa and stool samples: Metabolomic (targeted and untargeted) profile will be assessed in serum, stool and colonic mucosal biopsies. These analyses will show the difference in the metabolomic profile before and after the intervention.


Secondary Outcome Measures :
  1. Biomarkers of bone turnover / metabolism. [ Time Frame: 90 days ]
    In serum and urine: Serum biomarkers of bone turn-over (osteocalcin, procollagen type 1 N propeptide; P1NP , serum collagen type 1 cross-linked C-telopeptide; CTX, bone-specific alkaline phosphatase and tartrate-resistant acid phosphatase;TRAP-5b) will be assessed. Urinary collagen type 1 cross-linked N-telopeptide; NTX and urinary collagen type 1 cross-linked C-telopeptide; CTX will also be assessed pre and post intervention.

  2. Biomarkers of liver function [ Time Frame: 90 days ]
    In serum: Serum levels of hepatic enzymes; Alanine transaminase (ALT), Aspartate aminotransferase (AST) and Alkaline phosphatase (ALKP) will be assessed pre and post intervention.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be able to give written informed consent.
  • Be generally healthy, male or female, ages 18 to 80 years old.
  • Must have one of the following:

    i)A first degree relative (father/mother, son/daughter, brother/sister) with colorectal cancer under the age of 60 at the time of diagnosis; OR ii)Participant have had a colorectal polyp. OR iii)Participant have previously had removed early stage colon cancer (stage I or II removed surgically and without recommendation for adjuvant therapy or with stage III colorectal cancer (CRC) treated with curative surgery >5 years ago). iv)Pre-menopausal women with intact female reproductive organs must have a negative pregnancy test within 2 weeks of the baseline flexible sigmoidoscopy. Post-menopausal is defined as no menses for the previous 12 months. If cessation of menses is within 12 months then the subject should be treated as pre-menopausal and a pregnancy test performed.

Exclusion Criteria:

  • Must not be pregnant or lactating women and women of child bearing potential unwilling to use acceptable birth control throughout the study.
  • Participants must not have a history or diagnosis of any of the following conditions:

    i)Kidney disease, including kidney "stones" or hypercalcemia. ii)Crohn's disease, or inflammatory bowel disease. iii)Any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors) or active gastric / duodenal ulcers - peptic ulcer disease (without bleeding in last 3 months). iv)Coagulopathy/hereditary hemorrhagic disorders/ or receiving therapeutic doses of Coumadin or heparin. v)Hereditary and familial polyposis (HNPCC/ familial adenomatous polyposis (FAP); Lynch Syndrome) because these are rare conditions with unique etiology.

  • Participants will be excluded if they have taken the following, within the last 14 days or are unwilling to forgo the following for 14 days prior to entry into the study:

    i)Calcium, Vitamin D, ginger, or fish oil supplements, including multivitamins that have low amounts of calcium/Vitamin D and fiber supplements. ii)Non-steroidal anti-inflammatory medications (NSAIDS), such as Aspirin or Ibuprofen (except for occasional pain control or low dose aspirin for cardiovascular disease prevention). iii)Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps your body to regulate your stress response, immune response and inflammation). iv)Cephalosporin antibiotics (e.g., rocephin, keflex, omnicef).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647671


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
James Varani
Investigators
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Principal Investigator: James Varani, PhD University of Michigan

Publications:
Aslam MN, Varani J: The Western-Style Diet, Calcium Deficiency and Chronic Disease Journal of Nutrition & Food Science 6(3): 496, 2016.

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Responsible Party: James Varani, Professor of Pathology, University of Michigan
ClinicalTrials.gov Identifier: NCT02647671     History of Changes
Other Study ID Numbers: HUM00076276
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by James Varani, University of Michigan:
Colon polyp
Colorectal cancer
Chemoprevention
Natural product

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Calcium
Calcium, Dietary
Calcium Carbonate
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents