Effects of Dietary Manipulation on Metabolism in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in circulating plasma levels of key metabolic regulators
研究概览
简要总结
This study will examine the potential changes in the blood levels of a recently discovered metabolic regulator in response to changes in diet in healthy adults. Our hypothesis is that in healthy adults key regulatory factors involved in lipid oxidation will respond to changes in diet, particularly fasting and diet-induced ketosis.
详细描述
There is scant data regarding the metabolic events that occur in humans during ketosis which may be brought about by fasting or ingestion of diets low in carbohydrate.
We aim to employ both fasting and dietary manipulation in order to bring about a ketotic state in healthy human adults. During the study blood levels of key metabolic regulators will be monitored 1) during a 16 hour fast followed by re-feeding and 2) during dietary induction of ketosis followed by re-feeding with a standard meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
- •Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure)
- •Uncontrolled hypertension (BP > 150/90 mmHg on or off antihypertensive medication)
- •Dyslipidemia
- •Tobacco, marijuana or intravenous drug use
- •Shift workers (night shift or alternating day/night shifts)
- •Recent weight loss (> 3 kg within 6 months of the screening visit)
- •Gastroparesis
- •Inflammatory bowel disease
- •Malignancy treated with chemotherapy within the past 3 years
- •History of pancreatitis
- •Depression or psychosis
- •Renal insufficiency (creatinine clearance < 50 ml/min)
- •Transaminases > 2x above the normal range
- •Known liver disease
- •Pregnancy within 6 months of the screening visit
- •Failure to use medically approved contraceptive methods
- •History of an eating disorder (anorexia, bulimia or laxative abuse)
- •History of surgery for the treatment of obesity (gastric banding, gastric bypass, gastric stapling)
- •New diagnosis of hypo or hyperthyroidism within 1 year of screening visit
- •History of alcohol abuse within the past 5 years
- •Seizure disorder
- •Kidney stones
结局指标
主要结局
Changes in circulating plasma levels of key metabolic regulators
时间窗: 1 week
次要结局
- A secondary outcome is change in energy expenditure with diet-induced ketosis.(1 week)
研究者
Jody Dushay
Principal Investigator
Beth Israel Deaconess Medical Center