Effects of Aquatic Plant Protein Source Wolffia Globosa (Mankai) on Weight Loss, Cardiometabolic State, and Patient's Satisfaction During the Preoperative Dietary Intervention Period in Patients Undergoing Bariatric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE
研究概览
简要总结
Candidates to bariatric surgery at The Bariatric and Metabolic Institute at Cleveland Clinic Florida are prescribed a high protein liquid diet for two weeks preoperatively and 2 weeks postoperatively. Whether Wolffia Globosa (Mankai), a plant based wholesome food, can serve as a natural alternative to liquid diet during the 2 week pre-operation and 2 weeks postoperation liquid based diet, is unknown.
The investigators aim to address the effect of daily Wolffia Globosa (Mankai) administration on morbid/severely-obese patients during the 2 week pre-operative period and 2 weeks postoperatively as compared to iso protein-iso caloric shake source on the following parameters
详细描述
This study is a prospective study involving patients selected for elective surgery. Patients undergoing bariatric surgery will be enrolled in this study and have several parameters checked as explained below. Patients selected and consented for elective bariatric surgery will be recruited in the Bariatric and Metabolic Institute to participate in this study and will undergo standard of care. The investigators will enroll approximately 120 candidates during a 6 months (~5 a week) period. Patients will be randomized to the A. control group: 3 traditional shakes or B. intervention group: 2 traditional shakes and 1 daily administration of substituting iso-protein green Wolffia Globosa (Mankai) Shake (4 frozen cubes of Wolffia Globosa (Mankai) equal to 20 grams of dry Wolffia Globosa (Mankai). Each shake will provide equivalent carbohydrate, calories and protein levels from the respective source. As part of our routine pre and postoperative screening and follow up protocol, the investigators will collect anthropometric and clinical data on all patients, including standard of care blood samples collected at 2 weeks pre operatively, surgery day and at 2 months postoperatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients that will undergo sleeve gastrectomy.
排除标准
- •Age below 18 years
- •American Society of Anesthesiologist (ASA) class IV or V
- •Patients using Vitamin-K antagonists
- •Patients with documented coagulopathies.
结局指标
主要结局
Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE
时间窗: 2 weeks
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis by fasting glucose and Hgb A1c
时间窗: 2 weeks
Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis (T2DM). measure by fasting glucose and Hgb A1c
Patient's liking with Wolffia Globosa (Mankai) shake measured with a questionnaire
时间窗: 2 weeks
Patient's liking with Wolffia Globosa (Mankai) shake. measured with a questionnaire
Patient's tolerance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
时间窗: 2 weeks
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
Patient's compliance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
时间窗: 2 weeks
QUALITY OF ALIMENTATION QUESTIONNAIRE is a questionnaire with 1 open ended question, 4 yes/no questions, and three 0-5 questions with 5 being the highest level
次要结局
- Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements(2.5 months)
- Adverse effect by patient report and clinical follow up(2.5 months)
- Fat% (via Bioelectrical Impedance)(2.5 months)
- Fatty liver infiltration by Ultrasound(2.5 months)
- Patient's adherence by food diary(2.5 months)
- Satisfaction of Patients by specific questionnaire(2.5 months)
- Free Fat Mass (via Bioelectrical Impedance)(2.5 months)
研究者
Emanuele LoMenzo
Principal Investigator, Director Department of Research,
Cleveland Clinic Florida