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

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
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Record History

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  1. Minor Primary completion pushed from Aug 2026 to Dec 2026 Show 6 more changesShow less
    • Interventions modified
    • Trial arms changed: 3 → 8
    • Study completion date: Jan 2027 to Mar 2027
    • Study description shortened, about 7 words
    • Study title revised
    • Eligibility criteria expanded, about 1 word
  2. Minor Re-verified, no change to tracked fieldsv11
  3. Notable Primary completion date: Aug 2025 to Aug 2026
    • Study completion date: Jan 2026 to Jan 2027
    v10
  4. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 115
    • Study completion date: Aug 2025 to Jan 2026
    • Site details revised
    v9
  5. Notable Primary and study completion dates: Aug 2023 to Aug 2025v8
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  1. Notable Primary and study completion dates: Aug 2022 to Aug 2023v7
  2. Minor Primary and study completion dates: Apr 2022 to Aug 2022v6
  3. Minor Primary completion date: Oct 2021 to Apr 2022
    • Study completion date: Feb 2022 to Apr 2022
    v5
  4. Notable Lead sponsor: Eran Elinav to Weizmann Institute of Sciencev4
  5. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Aug 2021 to Oct 2021
    • Start date changed from estimate of Apr 20, 2021 to Apr 21, 2021
    • Study description expanded, about 2 words
  6. Notable Start date: Feb 2021 to Apr 20, 2021v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04633369
Lead Sponsor Weizmann Institute of Science
Collaborators: Hadassah Medical Organization
Conditions
(from sponsor)
Dietary Fibers, Intermediate Fasting
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov