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The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix (GlycoFast84)

2026年7月2日 更新者:Jørn Wulff Helge、University of Copenhagen

The Effect of Fasting on Peak Fat Oxidation, Mitochondrial Coupling and Extracellular Matrix in Healthy Men and Lean and Obese Men and Women

The interventional study will recruit four groups (n=10 per group): Young men and women with normal weight (BMI 18-25), and young men and women with obesity (BMI >30). The study will investigate the effect of 84 hours of fasting on peak fat oxidation, mitochondrial coupling and the extracellular matrix.

研究概览

地位

招聘中

干预/治疗

详细说明

Four groups of young normal weight men (n=10) and women (n=10) and young obese men (n=10) and women (10) are recruited. After verbal and written information is provided signed consent is obtained.

Prior to the first day of the trial, the participants must complete a four-day dietary and exercise record based on the weighing of all food and beverages consumed and tracking all exercise. This is used to asses the participant's habitual diet and activity level. For female participants, an additional form must be completed regarding their menstrual cycle and form of contraception.

On the two trial days (before and after fasting), participants arrive at the laboratory in the morning, and on the first day, the participant will have fasted since the previous evening. Furthermore, participants have been asked to minimize strenous physical activity for 24 hours leading up to testing. Prior to day 1, participants have been instructed to consume a habitual carbohydrate-rich diet for the 48 hours preceding the first test day.

Initially, the participants' body composition is determined by DXA, after which the participants rest for 15 minutes. Subsequently, blood pressure is measured in the supine position whereafter resting energy expenditure is measured by indirect calorimetry. A venous blood sample is taken from the antecubital vein, as well as a biopsy from the m. vastus lateralis and from the subcutaneous abdominal adipose tissue using the Bergström technique applied with suction. After 30 minutes of rest, a graded exercise test on a cycle ergometer is initiated to determine peak fat oxidation and maximal oxygen uptake. After the test is completed and following a minimum of 10 minutes of rest, handgrip strength and knee extension strength are measured. This concludes the test day.

Thereafter, the 84-hour fast is initiated. During the fasting period, the subjects will communicate by telephone each morning with one of the researchers regarding their well-being and any questions they may have. On day 2 subjects will do 1 hour of submaximal exercise. During the fasting subjects will be provided with electrolyte tablets. Following the 84 hours, the subjects return to the laboratory. Here, the same protocol as described above is carried out. This concludes the test day and the experiment.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Copenhagen、丹麦、2200
        • 招聘中
        • Department of Biomedical Sciences
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Healthy normal weight men aged [18,40] and BMI [18,25]
  • Healthy normal weight women [18,40] and BMI [18,25]
  • Healthy obese men [18,40] and BMI [30,40]
  • Healthy obese women [18,40] and BMI [30,40]

Exclusion Criteria:

  • Present or former cardiovascular disease and chronical inflammatory disease
  • Consumption of medications and supplements that influence substrate use at rest and/or during exercise
  • Pregnancy

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Young normal weight men
BMI [18, 25] Age [18, 40]
Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
实验性的:Young normal weight women
BMI [18, 25] Age [18, 40]
Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
实验性的:Young obese men
BMI [30, 40] Age [18, 40]
Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.
实验性的:Young obese women
BMI [30, 40] Age [18, 40]
Long-term fasting (84 hours), physiological testing before and after fasting: sampling of blood, abdominal adipose tissue and skeletal muscle for molecular analysis and respiratory measurements at rest.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The effect of fasting and obesity on protein glycosylation of the extracellular matrix in adipose tissue
大体时间:The fasting will last approximately 84 hours.
The composition and protein glycosylation of the extracellular matrix will be measured in abdominal subcutaneous adipose tissue samples in 20 healthy normal weight men and women and 20 healthy obese men and women.
The fasting will last approximately 84 hours.

次要结果测量

结果测量
措施说明
大体时间
The effect of fasting and obesity on peak fat oxidation
大体时间:The fasting will last approximately 84 hours
40 participants (20 healthy normal weight men and women and 20 healthy obese men and women) will fast for 84 hours. Before and after the fast, peak fat oxidation (mg fat/min) is measured in an incremental bike test using indirect calorimetry.
The fasting will last approximately 84 hours

其他结果措施

结果测量
措施说明
大体时间
The effect of fasting and obesity on adipose tissue lipolytic capacity, muscle ketone oxidative capacity and mitochondrial coupling.
大体时间:The fasting will last approximately 84 hours.
The lipolytic capacity will be measured in abdominal subcutaneous adipose tissue samples and the capacity for ketone oxidation in vastus lateralis muscle in 20 healthy normal weight men and women and 20 healthy obese men and women.and In addition mitochondrial respiratory capacity will be measured in the muscle and adipose biopsy samples using high-resolution respirometry (Oxygraphs, Oroboros).
The fasting will last approximately 84 hours.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2033年12月1日

研究注册日期

首次提交

2026年6月19日

首先提交符合 QC 标准的

2026年7月2日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

When the experiments are concluded and the paper(s) are accepted that data will be able upon reasonable request

IPD 共享时间框架

The data will be available after publication and indefinately

IPD 共享访问标准

Not known at this state

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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