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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
3
Substituting the standard high protein, low carbohydrate preoperative shake during the preoperative liquid diet with Wolffia Globosa (Mankai) shake consisting of 16 oz of skim milk + 1 frozen cube of Wolffia Globosa (Mankai) +/- sugar substitute.
Cleveland Clinic Florida
Weston, Florida, United States
Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE
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
Time frame: 2 weeks
Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis by fasting glucose and Hgb A1c
Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis (T2DM). measure by fasting glucose and Hgb A1c
Time frame: 2 weeks
Patient's liking with Wolffia Globosa (Mankai) shake measured with a questionnaire
Patient's liking with Wolffia Globosa (Mankai) shake. measured with a questionnaire
Time frame: 2 weeks
Patient's tolerance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
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
Time frame: 2 weeks
Patient's compliance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
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
Time frame: 2 weeks
Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements
Serum levels of the common nutritional parameters will be checked before and after the intervention
Time frame: 2.5 months
Adverse effect by patient report and clinical follow up
Adverse effect patient report and clinical follow up
Time frame: 2.5 months
Fat% (via Bioelectrical Impedance)
Fat% (via Bioelectrical Impedance)
Time frame: 2.5 months
Fatty liver infiltration by Ultrasound
Fatty liver infiltration by Ultrasound
Time frame: 2.5 months
Patient's adherence by food diary
Patient's adherence by food diary
Time frame: 2.5 months
Satisfaction of Patients by specific questionnaire
Satisfaction of Patients. by specific questionnaire
Time frame: 2.5 months
Free Fat Mass (via Bioelectrical Impedance)
Free Fat Mass (via Bioelectrical Impedance)
Time frame: 2.5 months
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