NCT04452916已完成不适用
Physiological Response to Prolonged Fasting in Healthy Volunteers
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
- 55
- 试验地点
- 1
- 主要终点
- Resting Energy Expenditure
研究概览
简要总结
To investigate energy metabolism, anthropometry, blood pressure, gut microbiome, serum metabolome, glucose variability and neural mechanisms of food choice and mood before and after 5 days of fasting as well as their persistence in healthy men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women
- •20-50 years
- •Body mass index 20-30 kg/m2
排除标准
- •Clinically relevant heart, lung, liver, and kidney diseases
- •Any prescribed medication (except for oral contraceptives)
- •Current or chronic infection
- •Intake of antibiotics within 6 months before study entry
- •Fasting week within 6 months before study entry
- •Habitual use of dietary supplements
- •Food intolerances
- •Pregnancy, lactation
- •Vegan diet
- •In addition for fMRI: sensorineural hearing loss, tinnitus, metal implants, electric devices
研究组 & 干预措施
Waiting list control
Placebo Comparator
Starts with 5 days of Buchinger fasting after a waiting period of 12 weeks
干预措施: Buchinger fasting (Other)
Fasting
Active Comparator
Starts immediately with 5 days of Buchinger fasting
干预措施: Buchinger fasting (Other)
结局指标
主要结局
Resting Energy Expenditure
时间窗: 6-th day of fasting compared to baseline
Measured by indirect calorimetry (kcal/d)
次要结局
- Resting Respiratory Exchange Ratio(6-th day of fasting and 28 days after fasting compared to baseline)
- Fecal and serum metabolome(6-th day of fasting and 12 weeks after fasting compared to baseline)
- Neural correlates of emotion processing(6-th day of fasting and 12 weeks after fasting compared to baseline)
- Perceived Stress Questionaire (PSQ)(6-th day of fasting and 12 weeks after fasting compared to baseline)
- International Physical Activity Questionaire (IPAQ, long version)(6-th day of fasting and 12 weeks after fasting compared to baseline)
- Office systolic blood pressure(6-th day of fasting and 12 weeks after fasting compared to baseline)
- Fecal microbiome composition(6-th day of fasting and 12 weeks after fasting compared to baseline)
- Resting Energy Expenditure - Recovery(12 weeks after fasting compared to baseline)
- Glucose variability(From 3 days before until 6 days after fasting)
- Office diastolic blood pressure(6-th day of fasting and 12 weeks after fasting compared to baseline)
- Change in immune cell phenotypes(6-th day of fasting and 12 weeks after fasting compared to baseline)
- Neural correlates of food-specific delay discounting(6-th day of fasting and 12 weeks after fasting compared to baseline)
- Perceived Self Efficiency(6-th day of fasting and 12 weeks after fasting compared to baseline)
- PANAS Positive Affect Subscale (GESIS Panel)(6-th day of fasting and 12 weeks after fasting compared to baseline)
- PANAS Negative Affect Subscale (GESIS Panel)(6-th day of fasting and 12 weeks after fasting compared to baseline)
研究者
Sylvia Bähring, PhD
Principal Investigator
Charite University, Berlin, Germany
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Long-term Fasting: Multi-system Adaptations in HumansFastingNCT05031598Buchinger Wilhelmi Development & Holding GmbH62
已完成
不适用
Expression of Longevity Genes in Response to Extended FastingCardiovascular DiseaseNCT01059760Intermountain Health Care, Inc.30
已完成
不适用
Scientific study to know the effect of fasting and food in excessive weight individualsCTRI/2018/02/011978Ministry of AYUSH Government of India88
已完成
不适用
Short Term Intermittent Fasting and Mediterranean DietGlucose IntolerancePre-hypertensionOverweightHypertensionHypercholesterolemiaNCT02148458Washington University School of Medicine53
已完成
不适用
Effects of Prolonged Fasting on Microbiome and HDLFastingNCT03487679University of California, Davis21