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<p>This multicenter, prospective, randomized controlled trial (NCT03285152) evaluates the primary endpoint of feasibility of a very-low carbohydrate diet (VLCD) in 19 women with obesity/overweight and endometrial cancer, who are randomized 2:1 to either a VLCD or a standard diet for 21–28 days. Fifteen participants complete the study, with 91 ± 4% of VLCD meals consumed, 5.5 ± 0.8% weight lost, and no grade 3/4 adverse events. Secondary endpoints include assessments of tumor biology and circulating metabolic biomarkers. Fasting glucose and insulin fall 22 ± 5.9% and 60 ± 3.8%, while total cholesterol and low-density lipoprotein (LDL) rise 6 ± 2.7% and 17.8 ± 8.9%. In a pre-specified exploratory outcome, RNA-Seq shows enrichment of CD8 + T-cells (q &lt; 0.034; NES &gt; 1.75), confirmed by immunohistochemistry (IHC) showing CD8 + T-cells infiltration of the tumor margins (q = 0.034; NES = 1.75). We conclude that VLCD is feasible and well-tolerated.</p>

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Very low-carbohydrate ketogenic diet in treatment-naïve women with endometrial cancer and overweight: a randomized feasibility study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月27日

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  • Ezequiel Dantas,
  • Katie C. Hootman,
  • Jenna Moyer,
  • Morgan Tomberlin,
  • Katherine Curran,
  • Bhavani Ramesh,
  • Hannah Price,
  • Jeshua Kim,
  • Alex C. McPherson,
  • Maurice A. Hurd,
  • Yuan-Shan Zhu,
  • Andrew J. Plodkowski,
  • Erica Nagase,
  • Anastasia Tsomides,
  • Brandon M. Cuevas,
  • M. Laura Martin,
  • John Nguyen,
  • Gabrielle Bennetti,
  • Gissell Botero Rodriguez,
  • Kaity Chang,
  • Marissa Mezzancello,
  • Ginger J. Gardner,
  • Vance Broach,
  • Jennifer J. Mueller,
  • Yukio Sonoda,
  • Oliver Zivanovic,
  • Mario M. Leitao Jr,
  • Alexia Iasonos,
  • Krysten Soldan,
  • Karen Carthew,
  • Vania Hom,
  • Francis N. Villamater,
  • Rema Rao Chaari,
  • Kathryn Gorski,
  • Michael Sigouros,
  • Carol Aghajanian,
  • Olivier Elemento,
  • Lewis C. Cantley,
  • Benjamin D. Hopkins,
  • Britta Weigelt,
  • Lora H. Ellenson,
  • Kari Hacker,
  • Nadeem R. Abu-Rustum,
  • Vicky Makker,
  • Marcus D. Goncalves

摘要

This multicenter, prospective, randomized controlled trial (NCT03285152) evaluates the primary endpoint of feasibility of a very-low carbohydrate diet (VLCD) in 19 women with obesity/overweight and endometrial cancer, who are randomized 2:1 to either a VLCD or a standard diet for 21–28 days. Fifteen participants complete the study, with 91 ± 4% of VLCD meals consumed, 5.5 ± 0.8% weight lost, and no grade 3/4 adverse events. Secondary endpoints include assessments of tumor biology and circulating metabolic biomarkers. Fasting glucose and insulin fall 22 ± 5.9% and 60 ± 3.8%, while total cholesterol and low-density lipoprotein (LDL) rise 6 ± 2.7% and 17.8 ± 8.9%. In a pre-specified exploratory outcome, RNA-Seq shows enrichment of CD8 + T-cells (q < 0.034; NES > 1.75), confirmed by immunohistochemistry (IHC) showing CD8 + T-cells infiltration of the tumor margins (q = 0.034; NES = 1.75). We conclude that VLCD is feasible and well-tolerated.