Montag Ist Fasten-Tag (German) - MIFT [Monday is Fasting Day]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Insulin-like growth factor 1 and brain-derived neurotrophic factor
研究概览
简要总结
The aim of this pilot study is to evaluate the effects of one regular fasting day per week over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.
详细描述
Participants in the intervention group receive an initial group training for fasting. Then all participants will observe one fixed fasting day per week (monday) over a total period of eight weeks.
Participants in the control group receive an initial group training for healthy diet according to current German guidelines (DGE). Moreover, they will receive the same offer as in the intervention group at the end of the 8-week study period. Until then the control group participants follow a regular healthy diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 是
入选标准
- •age 18 -65 yrs
- •written informed consent
排除标准
- •severe chronic comorbidity
- •eating disorders
- •pregnancy
- •planed pregnancy
- •simultaneous participation in other trials
研究组 & 干预措施
Fasting
Intermittent fasting over 8 weeks (one day per week)
干预措施: Fasting / Caloric Restriction (Other)
Healthy diet
Regular healthy diet according to current German (DGE) guidelines for healthy nutrition.
干预措施: Healthy Diet (Other)
结局指标
主要结局
Insulin-like growth factor 1 and brain-derived neurotrophic factor
时间窗: Baseline and after 8 weeks
Measurement of changes after 8 weeks
次要结局
- Profile of mood states questionnaire: POMS(Baseline, 8 weeks, 6 month)
- Anxiety and depression questionnaire: HADS(Baseline, 8 weeks, 6 month)
- Flourishing questionnaire(Baseline, 8 weeks, 6 month)
- Visual analogue scales and Likert-scales(Baseline, 8 weeks, 6 month)
- Quality of life questionnaire: WHO-5(Baseline, 8 weeks, 6 month)
- Systolic and diastolic bloodpressure(Baseline, 8 weeks)
- Body Impedance Analysis (BIA)(Baseline, 8 weeks)
- Body weight and abdominal circumference(Baseline, 8 weeks)
- Blood: total cholesterol, LDL, HDL, Triglycerides; Insulin, GOT,GPT, GGT, AP; HbA1c; PTT, INR(Baseline and 8 weeks)
研究者
Andreas Michalsen
Prof. Dr. med. Andreas Michalsen
Charite University, Berlin, Germany