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临床试验/NCT05861362
NCT05861362已完成不适用

Feasibility and Metabolic Effects of a 5:2 Fasting Intervention in Women With Breast Cancer During Radiotherapy

MVZ Leopoldina GmbH2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年6月1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
发起方
入组人数
13
试验地点
2
主要终点
Longitudinal changes in skeletal muscle mass

研究概览

简要总结

The intervention consists of the adoption of a 5:2 intermittent fasting diet during radiotherapy of breast cancer patients. The aim of the study was to assess the feasibility of this intervention and its impact on body composition and selected metabolic blood parameters.

详细描述

The 5:2 intermittent fasting (FAST) intervention consisted of two nonconsecutive days of fasting per week that could be chosen freely according to the patient's weekly schedule. The minimum amount of time to count as a fasting day was 24 hours, but patients were advised to aim for a complete fasting day including the nights before and after that day. On a fasting day, only water and unsweetened tea or coffee was allowed. However, given that fat is the macronutrient interfering the least with the metabolic adaptions to fasting, while carbohydrates disturb the most [26], patients were allowed to consume small amounts of bone broth/meat broth, coconut oil, butter/ghee or heavy cream as an "emergency plan", i.e., in case that they felt they needed some energy-containing foods to complete an initiated fasting day.

The primary study outcome was the feasibility of the FAST intervention and its effects on longitudinal body composition changes from baseline until the final week of radiotherapy (body mass, fat mass, fat-free mass, muscle mass, extracellular and total body water). Secondary endpoints were absolute changes in metabolic parameters, hormones, and overall quality of life scores in the FAST group. As a surrogate marker for insulin resistance, the triglyceride-glucose index (TyG) was calculated according to TyG=ln⁡(fasting triglycerides [mg/dl]×fasting glucose [mg/dl]/ 2).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Non-metastasized breast cancer
  • •Indication for curative radiotherapy

排除标准

  • •metallic body parts that would interfere with electric bioimpedance (BIA) measurements
  • •difficulties with understanding the aims of the study

研究组 & 干预措施

FAST

Experimental

5:2 intermittent fasting group

干预措施: Curative radiotherapy (Radiation)

FAST

Experimental

5:2 intermittent fasting group

干预措施: 5:2 intermittent fasting (Behavioral)

结局指标

主要结局

Longitudinal changes in skeletal muscle mass

时间窗: Through study completion, an average of 5 weeks

Skeletal muscle mass (in kg) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

Longitudinal changes in total body water

时间窗: Through study completion, an average of 5 weeks

Total body water content (in L) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

Longitudinal changes in extracellular water

时间窗: Through study completion, an average of 5 weeks

Extracellular water (in L) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

Dropout rate in the FAST intervention group

时间窗: Through study completion, an average of 5 weeks

Used to measure feasibility. The intervention is rated as feasible if dropout rate is \<30%

Longitudinal changes in body mass

时间窗: Through study completion, an average of 5 weeks

Body mass (in kg) is measured by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

Longitudinal changes in fat-free mass

时间窗: Through study completion, an average of 5 weeks

Fat-free mass (in kg) is estimated by a bioimpedance device with an integrated scale (seca mBCA, seca Deutschland, Hamburg, Germany).

次要结局

  • Change between baseline and final (average 5 weeks) TyG index(Through study completion, an average of 5 weeks)

研究者

发起方
MVZ Leopoldina GmbH
申办方类型
Other
责任方
Sponsor

研究点 (2)

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