The Effects of Fasting on Reprogramming of Lipid Metabolism and Bone Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Triglyceride carbon content and degree of saturation
研究概览
简要总结
Caloric restriction has beneficial metabolic effects in humans including weight loss and improvement in blood pressure and lipid levels. Intermittent fasting has emerged as a popular alternative to caloric restriction as it does not require daily adherence to a dietary protocol, but whether the benefits of fasting protocols are dependent on weight loss is not known. In this study, the investigators will explore the metabolic effects of fasting and evaluate whether these effects, including negative effects on bone metabolism, are independent of weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women, ages 21-45 years
- •BMI of at least 21 kg/m2 and up to and including BMI of 29 kg/m2
- •Normal thyroid function
- •Regular menses (women)
- •At least one first-degree relative with type 2 diabetes (T2D) and/or history of gestational diabetes
排除标准
- •Any chronic diseases including hypertension and Type 2 diabetes mellitus
- •Indication for lipid-lowering therapy in non-diabetics, using the more stringent AHA guideline cutoff (LDL>190 or an estimated 10-year ASCVD risk of >7.5%)
- •Chronic medications, including oral contraceptive pills
- •Pregnant and/or breastfeeding
- •History of an eating disorder
- •25-OH vitamin D level < 20 ng/mL
- •Active substance abuse, including alcohol
- •Subjects with a prior history of intermittent fasting
- •The study physician feels that the subject may not be able to safely complete the protocol or may place themselves at risk by undergoing the protocol
研究组 & 干预措施
Fasting with weight maintenance
Subjects will fast one-day per week for 12 weeks and maintain body weight
干预措施: Fasting arm (Behavioral)
Fasting with weight maintenance
Subjects will fast one-day per week for 12 weeks and maintain body weight
干预措施: Weight maintenance (Behavioral)
Fasting
Subjects will fast one-day per week for 12 weeks
干预措施: Fasting arm (Behavioral)
Counseling
Subjects will be counseled on optimal diet and activity recommendations to maintain/achieve a normal BMI (standard of care)
干预措施: Counseling (Behavioral)
结局指标
主要结局
Triglyceride carbon content and degree of saturation
时间窗: Baseline, 3 months
Change in triglyceride carbon content and degree of saturation (% variation explained by both carbon number and double bond number in a regression model) between Baseline and Final Intervention visits
Trabecular bone microarchitecture
时间窗: Baseline, 3 months
Change in trabecular bone volume fraction at the radius between Baseline and Final Intervention visits
次要结局
- Insulin sensitivity(Baseline, 3 months)
研究者
Pouneh K. Fazeli, MD
Associate Professor of Medicine
University of Pittsburgh