NCT04633369

The Role of the Microbiome in the Response to Dietary Fibers Intake During Intermediate Fasting

The Role of the Microbiome and Host Physiology in Personalized Human Response to Dietary Fibers Intake During Intermediate Fasting

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Weizmann Institute of Science · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Dietary fibers are generally not degraded by the endogenous digestive enzymes, but rather by the complex ensemble of microorganisms that reside in the human gut \[1\]. This ensemble, collectively known as the human gut microbiome, plays a key role in breaking down, fermenting, and ultimately converting such dietary fibers into a variety of beneficial metabolites, including most notably, short chain fatty acids (SCFA). These end products of fibers' fermentation affect host metabolism, immunity, and physiology, and have been implicated in multiple diseases including obesity, metabolic syndrome, diabetes, and cardiovascular diseases. Intermediate fasting, and in particular circadian intermediate fasting (i.e. 16 hours of fasting followed by 8 hours of allowed eating), has been shown to have positive associations with multiple health conditions as obesity, diabetes mellitus, cardiovascular disease, cancers, and neurologic disorders In this study, we will try to answer open questions utilizing the long fasting period during the day to investigate the isolated effect of dietary fiber consumption, uncovering the degradation effect, but not the bulking effect, on the microbiome and the host physiology, and in particular its glucose response.

Detailed description

During the 22 days of the study, participants will wear a continuous glucose monitor, fill a daily food diary, and collect stool and oral samples which will be used for microbiota profiling. Participants will be asked to carry out an intermediate fasting regime, which will include: 16 straight hours of fasting followed by 8 hours which the participants will be allowed to eat. Drinking water is allowed throughout the fasting hours. The groups will consume 4, 12, 20 grams of the dietary fiber per day, according to the group they were assigned to, while not exceeding the total fiber consumption of 50 grams per day, which is considered a high-fiber diet.

Conditions

• Dietary Fibers
• Intermediate Fasting

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	dietary fibers	during days 13-22 the participants will consume the dietary fiber according to their randomization and continue fasting. Participants will be asked to collect stool and oral samples 4 times during this period.

Timeline

• Start date: 2021-04-21
• Primary completion: 2026-08-01
• Completion: 2027-01-01
• First posted: 2020-11-18
• Last updated: 2026-03-19

Locations

1 site across 1 country: Israel