Oral Supplementation of a Encapsulated Calcium Butyrate (ButiShieldTM) Supports Gut Health in Healthy Adults with Mild GI Symptoms
Introduction
ButiShield™, an encapsulated calcium butyrate supplement using proprietary spray-freezing MicroPEARLS™ technology, was developed to overcome odor and rapid absorption barriers. This study evaluated the efficacy, safety and tolerability of ButiShield™ in healthy adults with mild GI symptoms.
Objective
Butyrate is a short-chain fatty acid produced through gut microbiota fermentation1 of dietary fibers. ButiShield™, an encapsulated calcium butyrate supplement using proprietary spray-freezing MicroPEARLS™ technology, was developed to overcome odor and rapid absorption barriers that limit this ingredient in the human supplement space. This study evaluated the efficacy, safety and tolerability of ButiShield™ in healthy adults with mild GI symptoms.
Method
A single-arm, 6-week clinical trial enrolled 20 participants (75% female) with mild GI symptoms, consuming a typical Western diet. Participants consumed 600 mg ButiShield™ ( ≥210 mg butyric acid; >42 mg calcium) once per day. The primary outcome was the change from baseline to 6-weeks on GI symptom severity for the indigestion domain from the Gastrointestinal Symptom Rating Scale (GSRS). Other outcome measures included Digestion-associated Quality of Life Questionnaire [DQLQ], intestinal permeability biomarkers, hematology, clinical chemistry and safety.
Results
By day 8 and sustained for 6 weeks, participants reported significant improvements in the primary outcome for indigestion and all other GI symptoms (P<0.001, except diarrhea). This represented a 39% improvement in symptom severity from mild to minor discomfort. Similarly, DQLQ scores decreased by 41% (P<0.001), which represented a reduced frequency of disruptive digestive events from occasionally to rarely. Other significant findings included reductions in glucose (7%) and LDL cholesterol (7%) (P<0.05).
Conclusion
Overall, Butishield™ was efficacious and well tolerated, with no serious adverse events. This clinical study highlights ButiShield™ as a promising novel solution for not only intestinal and extra-intestinal health benefits, but also in enhancing gastrointestinal quality of life in healthy individuals.
Clinical Trial Registration - NCT06397482, Reviewed by Sterling Institutional Review Board, Study run by BioFortis
References
1. Guilloteau et al. (2010). Nutrition research reviews, 23(2), 366–384.