A Safety and Feasibility Study of Water-only Fasting and Refeeding for Treatment of Stage 1 and 2 Hypertensive Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Determine number of treatment-associated of grade 1-4 adverse events as assessed by CTCAE v5.0
研究概览
简要总结
This purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.
详细描述
This is a prospective, open label, single arm, intervention study to examine the safety and feasibility of water-only fasting to treat hypertensive patients. Additional aims include describing mean changes in resting blood pressure as well as markers of cardiovascular health and inflammation between baseline and end of fast, end of refeed, 6-weeks post departure, and 12-months after 6-weeks follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30-75 years old
- •Diagnosis of Stage 1 or 2 hypertension
- •Fasting plasma glucose <126mg/dL and/or hemoglobin A1c <7 percent
- •Elect and qualify for a water-only fast of at least 7 consecutive days
- •Provide informed consent
- •Internet and computer access
- •Able to go to LabCorp for 6-week follow-up visit
- •Willing/able to collect 24-hour urine sample prior to water-only fasting
排除标准
- •Systolic Blood Pressure/Diastolic Blood Pressure >180/120 mmHg
- •Active malignancy
- •Active kidney disease (creatinine over 2.0)
- •Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)
- •Stroke, heart attack, deep vein thrombosis, atrial fibrillation, anticoagulant therapy, or pulmonary embolism within the last 12 months
- •Inability to discontinue medications or supplements
- •Abdominal metal implants
- •Inability to consume only plant food for at least 48 hours before fast begins.
- •Unable to lay still on the back for at least 10 min.
结局指标
主要结局
Determine number of treatment-associated of grade 1-4 adverse events as assessed by CTCAE v5.0
时间窗: up to 10-60 days after baseline
Adverse events will be identified through participant interviews and medical record review
次要结局
- Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on change in systolic blood pressure (SBP)(Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after departure, 12-months after 6-weeks follow-up)
- Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on treatment acceptability(Up to 7-40 days after baseline and 6-weeks after end of refeed)
- Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on food acceptability(6-weeks after end of refeed)
- Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on dietary adhernece(6-weeks after end of refeed)
研究者
Toshia Myers
Director
TrueNorth Health Foundation