Controlled Clinical Trials in Humans
Muhammad N. Aslam, MBBS (he/him/his)
Assistant Research Sciecntist
University of Michigan
Ann Arbor, Michigan, United States
Introduction. The long-term objective of our research is to ascertain whether, and to what extent, a multimineral product (Aquamin) can have a beneficial impact on individuals with ulcerative colitis (UC). In pursuit of this goal, we conducted a 180-day biomarker trial involving UC patients who were either in remission or at a mild-to-moderate stage of the disease.
Approach. A total of 28 subjects participated in the study. They were randomized to receive either Aquamin for 180 days or a placebo (maltodextrin) for 90 days while continuing their UC therapy. On day 90, subjects in the placebo group crossed over to receive Aquamin for the remaining 90 days. Serum samples were collected at baseline (day 0), mid-point (day 90), and study end (day 180) to measure C-reactive protein (CRP), alkaline phosphatase (ALP), intestine-specific ALP (ALPI), and biomarkers of bone turnover (osteocalcin, TRAP5b, and bone-specific ALP [BALP]). Stool specimens were evaluated for fecal calprotectin at the same time points, and colon biopsies were examined histologically for Geboes scoring. Dual-energy X-ray absorptiometry (DEXA) scans were performed at baseline and study end (day 0 and day 180). Additionally, a mass spectrometry-based proteomic assessment of colon biopsy specimens was conducted at each time point.
Results. Subjects who received Aquamin for the full 180-day period (12 subjects) demonstrated improvements in UC disease-related biomarkers; these improvements were not observed in the placebo group (16 subjects). Subjects who received Aquamin for 90 days exhibited intermediate responses. Additionally, subjects receiving Aquamin for 180 days showed increased bone mineral density (BMD) and bone mineral content (BMC), resulting in a statistically significant increase in the hip strength index over the treatment period. This was accompanied by increases in osteocalcin and TRAP5b, and a decrease in BALP. The proteomic screening revealed upregulation of multiple gut barrier proteins, cell surface transporter molecules, and certain proteins with anti-inflammatory potential in response to Aquamin. Aquamin treatment also led to the downregulation of several proteins associated with the pro-inflammatory state.
Conclusion. The results presented here demonstrate that a multimineral intervention can enhance the gut barrier and improve disease-related biomarkers in patients with UC. An additional benefit includes improvements in bone health. These findings suggest the potential value of the multimineral intervention as a low-cost, non-toxic adjuvant therapy for mild to moderate UC or for those in remission.