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.

Previous studies by the authors showed that improvements in cardiometabolic traits from intermittent fasting are associated with gut microbiome remodeling, particularly involving SCFA-producing bacteria.

• The cardiometabolic improvements from intermittent fasting were associated with remodeling the gut microbiome
• Short-chain fatty acids (SCFA) producing bacteria were specifically identified as evident in this remodeling
• These effects are largely lost when intermittent fasting is discontinued

Konjac mannan oligosaccharides (KMOS) are a commercial prebiotic reported to increase levels of intestinal SCFA-producing bacteria.

• KMOS are described as a 'commercial nature-deprived prebiotic'
• KMOS has been reported to increase levels of intestinal SCFA-producing bacteria
• Whether continued KMOS consumption can maintain intermittent fasting-provoked levels of SCFA-producing bacteria was unknown at the time of protocol development

The trial protocol involves overweight volunteers aged 18-65 performing one month of intermittent fasting followed by one month of an ad libitum diet.

• Participants are overweight volunteers aged 18-65
• All participants perform one month of intermittent fasting
• This is followed by one month of an ad libitum diet
• The study is registered under ChiCTR2200058139
• The design is described as a prospective, randomized, controlled trial

Participants are randomly assigned to one of three groups receiving KMOS at a dose of 1.5 g/d under different timing conditions.

• KMOS dose is 1.5 g/d
• Group 1 receives KMOS during fasting only
• Group 2 receives KMOS during both fasting and the subsequent ad libitum period
• Group 3 receives neither (control group)
• The trial is described as open-label

The primary outcomes of the trial are relative abundance of SCFA-producing bacteria in fecal samples as determined by 16S rRNA sequencing.

• Primary outcomes are relative abundance of SCFA-producing bacteria in fecal samples
• Measurement method is 16S rRNA sequencing
• Secondary outcomes include changes in body weight, blood pressure, and serum lipid levels