The objective of this research was to evaluate the efficacy, safety, and tolerability of supplementing a regular diet with a multi-enzyme blend derived from fungal fermentation.

A total of 120 participants (63 male, 57 female), aged 18–59 years, were enrolled. They were randomly assigned in a 1:1 allocation ratio to receive either two capsules per day of the food supplement (each containing 200 mg of the multi-enzyme blend) or a placebo for a period of two months.

The Nepean Dyspepsia Index-SF (NDI-SF) questionnaire measured the primary outcome of enhanced quality of life in the study. The secondary endpoints, such as sleep quality and pain intensity were evaluated using the Pittsburgh Sleep Quality Index (PSQI) questionnaire and Visual Analogue Scale (VAS), respectively.

In this monocentric, randomized, placebo-controlled, double-blind clinical trial, subjects treated with the multi-enzyme blend showed enhancements in NDI-SF1, NDI-SF2–5, VAS, and PSQI scores. These improvements indicated an elevated quality of life and better sleep, coupled with reduced pain severity, as a result of digestive enzyme supplementation. Importantly, these positive outcomes were observed without any reported side effects.

The study revealed the positive impact of administering a multi-enzyme blend before lunch and dinner over two months for functional dyspepsia. Remarkable betterment was noted in dyspepsia symptoms, overall quality of life, and quality of sleep. This suggests that using this multi-enzyme blend is a safe, effective, and well-tolerated strategy for functional dyspepsia management.