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临床试验/NCT07216989
NCT07216989已完成不适用

Fastomics: Metabolic and Therapeutic Effects of Prolonged Fasting

University of Minnesota1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2025年8月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Feasibility of doing prolonged fasting in this population

研究概览

简要总结

This is an observational study investigating how the metabolic and cell marker changes in Prolonged Fasting in the serum may be used against a cell-based model of disease for therapeutic purposes.

详细描述

There is potential benefit to prolonged water fasting, fasting with ad libitum water intake and consciously eating little to no food or caloric beverages, with regards to reducing weight, fat mass, insulin resistance and oxidative stress while improving glycemic control. Multiple studies have shown that prolonged water-only Fasting for 5-20 days has been safe in humans. A minimum of 2-3 liters of water intake daily is recommended by previous studies in which longer periods of up to 8 days fasting were observed. Prolonged fasting (36 hours) in humans upregulated multiple bioactive metabolites in the serum; exposure to this serum extended the lifespan of yeast (Caenorhabditis elegans) by 96%. In patients receiving chemotherapy, extended fasting periods of up to 60 hours (36 hours before and 24 hours after chemotherapy) are well-tolerated and reduce chemotherapy-related side effects, similar to shorter fasting durations of 28-48 hours. Herein, we propose an in-depth evaluation of Prolonged Fasting on serum metabolite measures and the effects of these serum metabolites on different cell-based models of disease (i.e. cancer, metabolic syndrome, diabetes). We hypothesize that Prolonged Fasting will alter serum metabolites to favorably improve cell-based models of disease. The significance of this study is to understand the extent of immune system activation and metabolic changes resulting from Prolonged Fasting. This sets the stage for developing tailored interventions to capture the fasting phenotype without the process of actually fasting.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ages of 18-65 years old
  • Not pregnant
  • No comorbid conditions
  • BMI of 18.5-29.
  • Has a smartphone

排除标准

  • Concern for active eating disorder per screening questionnaire
  • Self-reported eating disorder or history of eating disorder
  • History of hypoglycemia or contraindication for Prolonged Fasting
  • Weight <120lbs
  • History of blood donation within the last 3 months.

研究组 & 干预措施

60 Hour Fasting

healthy participants who agree to fast with water for up to 60 hours while wearing continuous glucose monitors

干预措施: Fasting (Other)

结局指标

主要结局

Feasibility of doing prolonged fasting in this population

时间窗: Day 4

measured by % participants completing all the visits

次要结局

  • Exposure of plasma on in vitro breast cancer cell models with regards to cell viability, signaling, function, plasma metabolites, and inflammatory markers(Baseline)
  • Exposure of plasma on in vitro breast cancer cell models with regards to cell viability, signaling, function, plasma metabolites, and inflammatory markers(After 60 hours of fasting)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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