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临床试验/NCT07155993
NCT07155993Enrolling By Invitation不适用

FastForward: A Prospective Analysis of Long-term Fasting and Subsequent Food Reintroduction in Humans

Buchinger Wilhelmi Development & Holding GmbH1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
1
主要终点
Body weight

研究概览

简要总结

This study explores what happens in the body and wellbeing during and after a period of long-term fasting. At the Buchinger Wilhelmi Clinic, participants follow a medically supervised fasting program lasting five or more days, followed by a structured food reintroduction phase. The study observes participants over time to better understand how fasting and the return to eating affect weight, metabolism, nutrition habits, and overall well-being.

All participants will complete online questionnaires during the fasting phase and for up to three months afterward. These surveys help track changes in lifestyle, mood, and health. In addition during the first two weeks after fasting ends participants wear a continuous glucose monitor (CGM) to track blood sugar levels in real time, use a mobile app to document meals with photos, and perform simple at-home blood tests using dried blood spot (DBS) kits.

By combining digital tools with personal reports and at home tests, the study aims to gain a clearer picture of how the body adapts after a prolonged fast. The goal is to better understand the short- and medium-term effects of extended fasting on metabolism, diet, and well-being-and to provide practical guidance for those interested in fasting as a health practice.

详细描述

Dear prospective study participants,

For optimal results of a fasting cure, the investigators would like to better understand the phase of food reintroduction, in which food is taken back after fasting.

The investigators would like to ask potential participants if they are willing to participate in the study of the Buchinger Wilhelmi Fasting Program. The study examines the post-fasting phase of food reintroduction. For this purpose, the first 14 days after the end of the fast are closely documented. This is done with the help of continuous glucose measurement and documentation of meals. In addition, various systemic biomarkers and the inflammatory status in blood are examined. In addition, further follow-up examinations take place after one and three months.

This study will include a total of more than 200 participants.

How will the study proceed and what investigations are planned?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women
  • Fasting for 5+ days at the Buchinger Wilhelmi clinic in Überlingen or Marbella
  • Age: 18-90 years old
  • Signed informed consent

排除标准

  • Not able to sign the informed consent
  • Diagnosed with cachexia, anorexia nervosa, advanced kidney, liver or cerebrovascular insufficiency.
  • Chronic manifest psychical and psychiatric diseases
  • Participation in another study
  • Pregnancy or breastfeeding

结局指标

主要结局

Body weight

时间窗: From the fasting start until 3 month after fasting

Changes in body weight in the three-month period after a 5+ day fasting period according to the Buchinger Wilhelmi fasting program

次要结局

  • Glycemic regulation(From the fasting start until 3 months after fasting)
  • Change in systemic inflammation(From the fasting start until 3 months after fasting)
  • Eating behaviour(From the fasting start until 3 months after fasting)
  • Resting energy expenditure(From baseline (D-1) to the last day of fasting (Day 5 to Day 25))
  • Adipose tissue composition(BIA: baseline (Day -1), Day 14, 1 month, and 3 months after fasting Fat biopsies: before fasting (Day -1) and immediately after fasting (last day of fast))
  • Wellbeing(From the fasting start until 14 days after fasting)
  • Lifestyle factors(From the fasting start until 3 months after fasting)
  • Ketone bodies(From the start of fasting until 2 weeks after fasting)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Siegler, MD

Principal Investigator

Buchinger Wilhelmi Development & Holding GmbH

研究点 (1)

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