A Randomized, Double-Blind, Placebo-Controlled Parallel Study Demonstrating the Efficacy of A-F Betafood® on Gallbladder Function (P06-125-19)

Abstract

ObjectivesTo evaluate the efficacy of A-F Betafood® on gallbladder and liver function in healthy overweight adults. MethodsA multi-center, randomized, double-blind, placebo-controlled parallel study was conducted on 50 healthy male and female adults 41–69 years of age, BMI 23.5–32.1 kg/m2 experiencing gastrointestinal distress when consuming fatty foods. Participants were randomized into two interventions: A-F Betafood® or placebo and consumed 2 tablets of the products with a meal, 3 times daily for 12 weeks. At baseline and week 12, liver function tests were performed as well as an ultrasound following a fat rich liquid meal to determine gallbladder volume, wall thickness, ejection fraction and ejection rate. Safety measurements included adverse events, vital signs, anthropometric measures, hematology and clinical chemistry. ResultsForty-two subjects completed the study. There was a significant 9% (p = 0.049) decrease in gallbladder wall thickness in participants supplemented with A-F Betafood® while those on placebo showed a 6% increase. Significant within-group reductions of 32% (p = 0.044) in gallbladder volume 30 minutes post-meal and a significant increase of 19% (p = 0.047) in ejection fraction were observed in participants in the A-F Betafood® group but not in the placebo group following the 12-week supplementation. Gallbladder ejection rate showed non-significant 15% increase in participants supplemented with A-F Betafood® while those on placebo showed an 8% decrease. Gallbladder volume, emptying and ejection fraction were not significantly different between A-F Betafood® and placebo. There were no clinically relevant adverse events and safety parameters remained within normal clinical ranges. ConclusionsHealthy participants, experiencing gastrointestinal distress when consuming fatty foods, showed clinically relevant improvements in gallbladder motility and gallbladder wall thickness without experiencing any adverse events when supplemented with A-F Betafood® for 12 weeks. Significant within group reductions in gallbladder volume and increases in ejection fraction, and non-significant increases in ejection rate are indicative of improvements in gallbladder motility suggesting a role for A-F Betafood® in populations at risk for gallbladder malfunction. Funding SourcesStandard Process Inc., Palmyra, WI.