NCT05080699Enrolling By Invitation不适用
Effect of Hypocaloric, High-protein Enteral Formula on Body Weight and Health Outcomes in Obese HEN Patients: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
The purpose of this study is to assess the effects of a low energy, high protein tube feeding formula on body weight in tube fed patients who are obese. It will also assess study formula tolerance as well as impact of the study formula on lean body mass, blood pressure, blood sugar and lipids.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Home Enteral Nutrition (HEN) patient receiving at least 90% of energy needs from enteral nutrition.
- •History of stroke.
- •Weight stable over the past month.
排除标准
- •Diagnosis of cancer undergoing active treatment (chemotherapy, radiation, immunotherapy).
- •Life expectancy of less than 6 months.
- •Stage IV or higher kidney disease (GFR < 30).
研究组 & 干预措施
Peptamen Intense in obese home enteral nutrition patients after stroke
Experimental
Subjects currently enrolled in Mayo Clinic Home Enteral Nutrition (HEN) program and anticipated to require tube feedings to provide 90% or more of feeding needs will be placed on a Peptamen Intense VHP for up to 12 weeks.
干预措施: Peptamen Intense VHP, Nestlé Health Science, Switzerland (Dietary Supplement)
结局指标
主要结局
Change in body weight
时间窗: Baseline, 3 months
Change in body weight, measured in kg
次要结局
- Change in LDL(Baseline, 12 weeks)
- Change in lean body mass(Baseline, 12 weeks)
- Change in systolic and diastolic blood pressure(Baseline, 12 weeks)
- Change in HbA1c(Baseline, 12 weeks)
- Change in total cholesterol(Baseline, 12 weeks)
- Change in c-peptide(Baseline, 12 weeks)
- Change in HDL(Baseline, 12 weeks)
- Change in percent goal calories provided with enteral nutrition(Baseline, 12 weeks)
- Change in percent goal proteins provided with enteral nutrition(Baseline, 12 weeks)
- Change in diabetes medications(Baseline, 12 weeks)
- Change in triglycerides(Baseline, 12 weeks)
- Change in tube feeding tolerance(Baseline, 12 weeks)
- Change in hand grip strength(Baseline, 12 weeks)
- Change in anti-hypertensive medications(Baseline, 12 weeks)
研究者
Manpreet S. Mundi
Principal Investigator
Mayo Clinic
研究点 (1)
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