The Effect of Intermittent Fasting on Adaptive Oxidative Stress Response and Mitochondrial Biogenesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- SOD2 gene expression (intermittent fasting)
研究概览
简要总结
Healthy volunteers will be recruited to participate in a ten-week double-blinded crossover trial. The trial will consist of two, three-week periods of intermittent fasting, where subjects receive either antioxidant supplementation or placebo, the ordering of which will be randomly determined. A one-week preconditioning will precede each invention period, and a two week "wash-out" period will follow the first intervention period. Serum-based assays will be performed to assess levels of reactive oxidant species, antioxidant genes, sirtuins, and markers of mitochondrial biogenesis and aging.
The investigators hypothesize that an intermittent fasting diet in healthy young volunteers will improve these markers of cellular aging and that these beneficial effects will be abrogated by the supplementation of antioxidants. This study is a proof-of-principle study that will shed light on the mechanism and effects of IF as an anti-aging dietary intervention in the absence of weight loss. It will inform the design of dietary interventions that are both effective in improving markers of aging and feasible for patients to practice on a long-term basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index in the range of 20.0-30.0 kg/m2;
- •Age between 19 and 30;
- •Stable weight (change <±10%) for 3 months immediately prior to the study
- •No history of metabolic disorders (e.g. non-diabetic), cardiovascular disease, or thyroid dysfunction
- •No past or present eating disorders
- •No acute or chronic inflammatory disorder
- •No more than moderate physical activity (i.e.,<3 hour/week of light exercise sessions for the past 3 months)
- •No current medications to regulate blood sugar or lipids
- •Not donated blood within 56 days of study start date
- •No food allergies
- •No dietary restrictions (e.g. vegetarianism and vegan)
- •No heavy drinking (more than 15 drinks/week)
- •No use of tobacco or recreational drugs within past 3 months
- •Access to a microwave or stove
- •Access to refrigeration
排除标准
- •Inflexibility of schedule such that subject cannot attend blood draw appointments
- •Unwillingness to pick-up and eat only study-provided food during the 8 weeks in which it is provided and for unwillingness to abstain from travel (>48hrs) during these same 8 weeks of the trial (travel is permitted during wash-out period)
- •Unwillingness to abstain from tobacco, alcohol, recreational drugs, resveratrol or antioxidant supplements (other than study-provided) for the duration of study
- •Women who are pregnant, breast-feeding or trying to become pregnant
结局指标
主要结局
SOD2 gene expression (intermittent fasting)
时间窗: 3 weeks
Observational outcome examines difference in expression between a normal diet and a 3-week intermittent fasting diet using RNA extracted from venous blood. Note: SOD2 = Superoxide-dismutase-2
SOD2 gene expression (antioxidant supplementation)
时间窗: 3 weeks
Experimental outcome examining differences between intermittent fasting with supplementation of antioxidants and intermittent fasting alone using RNA extracted from venous blood. Note: SOD2 = Superoxide-dismutase-2
次要结局
- GPx1 gene expression (intermittent fasting)(3 weeks)
- SIRT1 gene expression (intermittent fasting)(3 weeks)
- SIRT3 gene expression (intermittent fasting)(3 weeks)
- mTFA gene expression (intermittent fasting)(3 weeks)
- 8oxoG ratio (intermittent fasting)(3 weeks)
- GPx1 gene expression (antioxidant supplementation)(3 weeks)
- SIRT3 gene expression (antioxidant supplementation)(3 weeks)
- mFTA gene expression (antioxidant supplementation)(3 weeks)
- NRF1 gene expression (antioxidant supplementation)(3 weeks)
- 8oxodG ratio (antioxidant supplementation)(3 weeks)
- NRF1 gene expression (intermittent fasting)(3 weeks)
- 8oxodG ratio (intermittent fasting)(3 weeks)
- SIRT1 gene expression (antioxidant supplementation)(3 weeks)
- 8oxoG ratio (antioxidant supplementation)(3 weeks)