Clinical trial · Interventional
Aquamin and Prevention of Colon Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aquamin® | Drug | — | UNRESOLVED |
| Calcium Carbonate | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Aquamin®
- description
- Experimental: Aquamin® (4 capsules per day) - 4 capsules; 2 to be taken in the morning and 2 in the evening
- interventionNames
- Drug: Aquamin®
- type
- ACTIVE_COMPARATOR
- label
- Calcium Carbonate
- description
- Active Comparator: Calcium Carbonate (4 capsules per day) - 4 capsules; 2 to be taken in the morning and 2 in the evening
- interventionNames
- Drug: Calcium Carbonate
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo (Maltodextrin) - 4 capsules; 2 to be taken in the morning and 2 in the evening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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).
References
Publications (21)
- BACKGROUNDAslam MN, Bhagavathula N, Paruchuri T, Hu X, Chakrabarty S, Varani J. Growth-inhibitory effects of a mineralized extract from the red marine algae, Lithothamnion calcareum, on Ca(2+)-sensitive and Ca(2+)-resistant human colon carcinoma cells. Cancer Lett. 2009 Oct 8;283(2):186-92. doi: 10.1016/j.canlet.2009.03.037. Epub 2009 Apr 24. PMID 19394137
- BACKGROUNDAslam MN, Paruchuri T, Bhagavathula N, Varani J. A mineral-rich red algae extract inhibits polyp formation and inflammation in the gastrointestinal tract of mice on a high-fat diet. Integr Cancer Ther. 2010 Mar;9(1):93-9. doi: 10.1177/1534735409360360. Epub 2010 Feb 11. PMID 20150219
- BACKGROUNDAslam MN, Kreider JM, Paruchuri T, Bhagavathula N, DaSilva M, Zernicke RF, Goldstein SA, Varani J. A mineral-rich extract from the red marine algae Lithothamnion calcareum preserves bone structure and function in female mice on a Western-style diet. Calcif Tissue Int. 2010 Apr;86(4):313-24. doi: 10.1007/s00223-010-9340-9. Epub 2010 Feb 24. PMID 20180099
- BACKGROUNDAslam MN, Bergin I, Naik M, Hampton A, Allen R, Kunkel SL, Rush H, Varani J. A multi-mineral natural product inhibits liver tumor formation in C57BL/6 mice. Biol Trace Elem Res. 2012 Jun;147(1-3):267-74. doi: 10.1007/s12011-011-9316-2. Epub 2012 Jan 6. PMID 22222483
- BACKGROUNDAttili D, Jenkins B, Aslam MN, Dame MK, Varani J. Growth control in colon epithelial cells: gadolinium enhances calcium-mediated growth regulation. Biol Trace Elem Res. 2012 Dec;150(1-3):467-76. doi: 10.1007/s12011-012-9503-9. Epub 2012 Sep 19. PMID 23008064
- BACKGROUNDAslam MN, Bergin I, Naik M, Paruchuri T, Hampton A, Rehman M, Dame MK, Rush H, Varani J. A multimineral natural product from red marine algae reduces colon polyp formation in C57BL/6 mice. Nutr Cancer. 2012;64(7):1020-8. doi: 10.1080/01635581.2012.713160. Epub 2012 Oct 4. PMID 23035966