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<p>In healthy individuals, short cycles of a fasting-mimicking diet (FMD) decrease systemic inflammatory markers and improve metabolic health. Potential benefits of FMD have not been investigated in Crohn’s disease (CD). We conducted an open-label, randomized, controlled trial to assess the effects of FMD in adults with mild-to-moderate CD. Patients in the FMD group followed an FMD for five consecutive days per month for three consecutive months, returning to their regular baseline diet on non-FMD days. Control participants continued their baseline diet. The primary outcome of clinical response was a reduction in CD Activity Index (CDAI) of at least 70 points or CDAI of ≤150 after the third 5-day diet cycle. Forty-five patients in the FMD group (69.2%) and 14 patients in the control group (43.8%) met the primary outcome of clinical response (<i>P</i> = 0.03). Forty-two patients in the FMD group (64.6%) and 12 patients in the control group (37.5%) achieved the secondary outcome of clinical remission (<i>P</i> = 0.02). There was also a decline from baseline in fecal calprotectin (an inflammatory marker) in the FMD group compared with the control group (−22.0% versus 8.0%, <i>P</i> = 0.03). Exploratory analyses of plasma metabolites and peripheral blood mononuclear cell gene expression revealed post-FMD decreases in key inflammatory lipid mediators and immune-effector transcripts, concordant with reduced CD activity. Together, these findings demonstrate that FMD is superior to a baseline diet for inducing clinical response, clinical remission and biochemical improvement in mild-to-moderate CD, and support further investigation of FMD as an adjunctive therapy for chronic inflammatory diseases. ClinicalTrials.gov registration: <a href="https://clinicaltrials.gov/study/NCT04147585">NCT04147585</a>.</p>

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A fasting-mimicking diet in patients with mild-to-moderate Crohn’s disease: a randomized controlled trial

  • 期刊论文

  • 发表日期：

    2026年1月13日

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  • C. Kulkarni,
  • T. Fardeen,
  • J. Gubatan,
  • J. Ye,
  • K. Jarr,
  • E. Dickson,
  • H. Jang,
  • M. Temby,
  • A. Patel,
  • Y. Jiang,
  • G. Singh,
  • K. Keyashian,
  • S. Streett,
  • E. Ho,
  • G. Barber,
  • S. Singh,
  • D. Limsui,
  • N. Anaizi,
  • L. Becker,
  • S. P. Spencer,
  • D. Mehrish,
  • D. Perelman,
  • V. D. Longo,
  • V. Charu,
  • J. F. Ashouri,
  • M. M. Davis,
  • A. Habtezion,
  • J. L. Sonnenburg,
  • C. Gardner,
  • S. R. Sinha

摘要

In healthy individuals, short cycles of a fasting-mimicking diet (FMD) decrease systemic inflammatory markers and improve metabolic health. Potential benefits of FMD have not been investigated in Crohn’s disease (CD). We conducted an open-label, randomized, controlled trial to assess the effects of FMD in adults with mild-to-moderate CD. Patients in the FMD group followed an FMD for five consecutive days per month for three consecutive months, returning to their regular baseline diet on non-FMD days. Control participants continued their baseline diet. The primary outcome of clinical response was a reduction in CD Activity Index (CDAI) of at least 70 points or CDAI of ≤150 after the third 5-day diet cycle. Forty-five patients in the FMD group (69.2%) and 14 patients in the control group (43.8%) met the primary outcome of clinical response (P = 0.03). Forty-two patients in the FMD group (64.6%) and 12 patients in the control group (37.5%) achieved the secondary outcome of clinical remission (P = 0.02). There was also a decline from baseline in fecal calprotectin (an inflammatory marker) in the FMD group compared with the control group (−22.0% versus 8.0%, P = 0.03). Exploratory analyses of plasma metabolites and peripheral blood mononuclear cell gene expression revealed post-FMD decreases in key inflammatory lipid mediators and immune-effector transcripts, concordant with reduced CD activity. Together, these findings demonstrate that FMD is superior to a baseline diet for inducing clinical response, clinical remission and biochemical improvement in mild-to-moderate CD, and support further investigation of FMD as an adjunctive therapy for chronic inflammatory diseases. ClinicalTrials.gov registration: NCT04147585.