Konjac mannan oligosaccharides as a sustainer of fasting-associated gut microbiome signature after discontinuation of intermittent fasting in overweight individuals: A protocol for an open-label randomized clinical trial.

BACKGROUND: Our previous studies show that the improvement in cardiometabolic traits by intermittent fasting is associated with remodeling the gut microbiome, with short-chain fatty acids (SCFA) producing bacteria being evident. These effects, however, are largely lost when intermittent fasting is discontinued. Konjac mannan oligosaccharides (KMOS) are a commercial nature-deprived prebiotic, which has been reported to increase the levels of intestinal SCFA-producing bacteria. However, the capacity of continued KMOS consumption to maintain intermittent fasting-provoked levels of SCFA-producing bacteria, remains unknown.

METHODS: This study aims to test whether a KMOS supplement positively affects fasting-provoked SCFA-producing bacteria levels during, and in particularly, after discontinuation of intermittent fasting. This prospective, randomized, controlled trial will be conducted in overweight volunteers aged 18-65. All participants will perform one month of intermittent fasting followed by one month of an ad libitum diet. Participants will be randomly assigned to receive KMOS (1.5 g/d) during fasting, both during fasting and the subsequent ad libitum period, or neither. Primary outcomes will be relative abundance of SCFA-producing bacteria in fecal samples, as determined by 16s rRNA sequencing. Secondary outcomes will be changes in body weight, blood pressure, and serum lipid levels.

CONCLUSIONS: Findings from this trial will answer the question whether KMOS can maintain fasting-associated SCFA producer level and metabolic benefits when fasting is discontinued.

CLINICAL TRIAL REGISTRATION: ChiCTR2200058139.