A digestive enzyme and herbal dietary supplement reduces bloating in a single use in healthy adults: A randomized, placebo-controlled, cross over study

Abstract

Abstract Background Healthy individuals with no diagnosed gastrointestinal condition may suffer from occasional meal-related bloating, gassiness and discomfort that negatively affects quality of life. This study examined the effect and tolerability of a digestive enzyme and herbal dietary supplement to improve meal-related bloating, gassiness and discomfort. Methods Adults aged 18 to 45 (n = 25) with self-reported bloating or abdominal distension at least once per day after a meal and no preexisting condition or medication use that may cause bloating were enrolled. After obtaining informed consent, fasted participants were randomized to consume either placebo or test product and consume a test meal. Waist circumference was measured at baseline, and again with surveys at 30- and 90-minutes post meal. Survey questionnaires asked participants to rate the momentary severity of bloating, distended stomach, gas, and indigestion on a 4-point scale (severe, moderate, mild, absent). Following a 1-week washout, participants repeated study procedures with the other study product. Descriptive statistics were used for continuous and categorical values, with independent sample t-tests conducted to examine between group differences and paired t-tests to examine differences in waist circumference scores. Results Participants (n = 20) experienced 58% less abdominal distension as assessed by the waist circumference measure at 30 minutes (0.93 cm vs 1.50 cm, p = 0.04) and 68% less at 90 minutes with the test product compared to the placebo (0.94 cm vs 2.12 cm, p = 0.007). Overall, 80% of participants had less distension with the test product compared to the placebo. No significant differences were noted between questions assessing momentary bloating, distended stomach, gas nor indigestion. There was a trend to more strongly agree the test product was effective for overall feelings of bloating, stomach discomfort and distension, as well as indigestion, with 65% of participants reporting less stomach discomfort and 55% reporting feeling less gassy than normal with the test product. No product-related adverse events or discomfort was reported. Conclusions A dietary supplement containing a blend of digestive enzymes and herbal ingredients was well tolerated and effective at reducing post-meal abdominal distension compared to placebo in healthy subjects. Trial Registration: ClinicalTrials.gov, NCT05520411, Submitted August 26, 2022