Clinical Trial

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

Active, Not Recruiting
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2020-11-12; most recent amendment 2026-03-18.
Status change: Recruiting → Active, Not Recruiting 2025-02-23
Status change: Not Yet Recruiting → Recruiting 2021-05-30
Trial Details
NCT Number NCT04633369
Lead Sponsor Weizmann Institute of Science
Collaborators: Hadassah Medical Organization
Conditions Dietary Fibers, Intermediate Fasting
Enrollment 115 participants
Start Date 2021-04-21
Primary Completion 2026-08 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-19