Abstract
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/14 M, 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