Cellular Effects of Fasting Mimicking Diet In Humans: An Interventional, Randomized, Open Label, Parallel Assignment Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Autophagy flux
研究概览
简要总结
This study aims to evaluates autophagy in circulating white blood cells from generally healthy human volunteers exposed to fasting mimicking diet (FMD), a 5-day dietary regimen.
详细描述
Fasting-mimicking diet (FMD) was developed to mimic the endocrine and metabolic effects that water-only fasting, while providing a modest calories and essential nutrients. The health benefits of FMD are caused by several molecular mechanisms, including the reduction of body weight, ectopic fat storage, insulin levels, endogenous glucose production and IGF-1. Autophagy is a catabolic membrane-trafficking phenomenon observed in yeast and mammalian cells. Nutrient deprivation induces autophagy. Autophagy has been proposed to be a fundamental cellular process being linked to aging and the progression of age-related diseases. The objective of this study is to evaluate the effects of consuming two FMD formulations on the autophagy process in the cell.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability and willingness to provide written informed consent;
- •Ability and willingness to perform the study tests and adhere to study protocol (to the best of the participant's knowledge);
- •BMI 20-35 kg/m2 (inclusive) at screening;
排除标准
- •Diabetes treatment other than diet or metformin monotherapy;
- •History of gastric bypass;
- •Subjects with recent weight loss (>5%), use of weight loss medication, participated in a weight loss program in the past 3 months;
- •Type 1 diabetes (based on medical history provided at screening);
- •Use of immune suppression drugs;
- •Contraindication for study foods (special food needs and allergy);
- •Women who are pregnant;
- •Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).
- •Has any medical disease or condition that, in the opinion of the principal investigator (PI) or appropriate study personnel, precludes study participation* (*Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial);
结局指标
主要结局
Autophagy flux
时间窗: Baseline to day 8
PBMCs will be prepared with or without Chloroquine (autophagy flux inhibitor). LC3BI to LC3BII conversion, the lipidation of MAP1LC3B/LC3B (microtubule-associated protein 1 light chain 3 β), in the PBMCs will be accessed by western blot. Autophagy-dependent degradation of SQSTM1/p62, a receptor and scaffold protein interacting with LC3 and ubiquitinated proteins, will be accessed by western blot.
次要结局
- Metabolomic change(Baseline to day 8)
- Autophagy-related gene expression(Baseline to day 8)