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

NCT04633369 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Dietary Fibers
  • Intermediate Fasting

Interventions

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.

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER

  • Weizmann Institute of Science

    lead OTHER

Principal Investigators

  • Eran Elinav, Prof · Weizmann Institute of Science

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-21
Primary Completion
2026-08-31
Completion
2027-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04633369 on ClinicalTrials.gov