(P16-009-20) Fermented Soy Supplementation Improves Quality of Life Indicators: A Randomized, Placebo-Controlled, Double-Blind Trial in Adults Experiencing Heartburn

Objectives: The aim of this pilot study was to determine the effects of a fermented soy supplement on heartburn relief, gastrointestinal symptoms, and quality of life.

Methods: A 5-week, randomized, double-blind pilot study was conducted with adults (n=51; 37F/14M, 31±12y) experiencing mild or moderate heartburn. Following a 1-week baseline, participants self-treated heartburn symptoms with up to 3, 1 g sachets of a non-GMO soy flour fermented by Lactobacillus delbrueckii ssp. delbrueckii Rosell-187 or placebo (maltodextrin) sachets per incident for 3 weeks followed by a 1-week washout. Differences from baseline between treatments were compared using the Wilcoxon Signed Rank test (alpha 0.05). Symptom intensity at 5, 15 and 30-min post administration was assessed using a Likert-like scale (1, no symptoms to 5, severe discomfort). The Gastrointestinal Symptoms Rating Scale (GSRS) (1-no discomfort to 7-very severe discomfort) and Gastro-oesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) (4-strongly disagree to 0-strongly agree) were administered during baseline, intervention, and washout.

Results: No significant differences between intervention groups were seen for heartburn severity or frequency, GSRS syndromes or GERD-QOL domains. However, individual QOL items related to inconvenience of taking medications (-1.0±1.3 vs -0.04±1.8, P< 0.05), fear of eating (-1.4±1.3 vs -0.2±1.7, P< 0.05), inability to concentrate at work (-0.9±1.6 vs -0.3±1.0, P< 0.05), and disturbance of after-meal activities and rest (-1.6±1.5 vs -0.7±1.5, P< 0.05) significantly improved with fermented soy compared to control. In addition, the frequency of heartburn (0.3±0.3 vs 0.1±0.3, P< 0.05) and the GSRS symptoms of diarrhea (0.3±1.4 vs -0.3±1.2, P< 0.05) and bloating (0.7±1.7 vs 0.1±1.3, P< 0.05) were significantly improved during washout vs. baseline for the fermented soy group, demonstrating a possible carryover effect over time.

Conclusions: Further research is suggested to test the effect of daily supplementation of fermented soy on heartburn frequency, gastrointestinal symptoms and QOL in a trial of longer duration.

Funding Sources: Lallemand Bio-Ingredients