A CALCIUM-RICH MULTI-MINERAL INTERVENTION TO MODULATE COLONIC MICROBIAL COMMUNITIES AND METABOLOMIC PROFILES IN HUMANS: Results from a 90-day trial

Abstract

Aquamin, a calcium-, magnesium-, and multiple trace element-rich natural product has polyp prevention efficacy based on preclinical studies. The overall goal of this study was to determine the safety and tolerability of Aquamin when used as a dietary chemopreventative in humans. Additionally, we determined the effects of Aquamin on the colonic microbial community and attendant metabolomic profile. Thirty healthy male and female human participants were enrolled in a 90-day trial in which the effects of Aquamin (delivering 800 mg of calcium per day) were compared to those of calcium alone or placebo. Before and after the interventional period, colonic biopsies and stool specimens were obtained. All 30 participants completed the study without serious adverse events. There were no changes in liver function markers. Compared to pretreatment values, intervention with Aquamin led to a reduction in total bacterial DNA and a shift in the microbial community. Treatment with calcium alone also produced a decline in total bacteria, but smaller than seen with Aquamin, while no reduction was observed with placebo. In parallel with microbial changes, a reduction in bile acid levels and a slight increase in the level of the short chain fatty acid (SCFA) acetate in stool specimens from Aquamin-treated participants was noted. No change in bile acids or SCFAs was observed with calcium alone or placebo. We conclude from these studies that Aquamin is safe and tolerable in healthy human participants and may produce beneficial alterations in the colonic microbial community and the attendant metabolomic profile.

ULCERATIVE COLITIS-DERIVED COLONOID CULTURE: A Multi-Mineral-Approach to Improve Barrier Protein Expression

“…While colonoid culture does not provide a means to assess changes in the gut microbial community, we are (in parallel with the current study) conducting a 90-day interventional trial with Aquamin ® in healthy human subjects Clinicaltrials.gov; NCT02647671). In findings to date, Aquamin ® ingestion altered the colonic microbial profile and, concomitantly, decreased bile acids levels and increased the level of the major SCFA, acetate, as compared to placebo (or calcium alone) (34). While the ongoing interventional trial is being conducted with healthy volunteers, a similar study in patients with UC in remission has just begun (Clinicaltrials.gov; NCT03869905).…”