Aquamin and Prevention of Colon Cancer
|ClinicalTrials.gov Identifier: NCT02647671|
Recruitment Status : Active, not recruiting
First Posted : January 6, 2016
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colonic Cancer||Drug: Aquamin® Drug: Calcium Carbonate Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Aquamin® (4 capsules per day) - 4 capsules; 2 to be taken in the morning and 2 in the evening
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
90 days of placebo
Other Name: Maltodextrin
- 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.
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647671
|United States, Michigan|
|University of Michigan Hospital|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||James Varani, PhD||University of Michigan|