Effects of Wolffia Globosa (Mankai) in Patients Undergoing Bariatric Surgery.

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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.

Conditions
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Bariatric Surgery Candidate, Diet Modification

Intervention / Treatment
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* Other: Dietary modification with introduction of Mankai


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patients that will undergo sleeve gastrectomy. Exclusion Criteria: Age below 18 years American Society of Anesthesiologist (ASA) class IV or V Patients using Vitamin-K antagonists Patients with documented coagulopathies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mankai Group<br>The pre-operative liquid diet will be started two weeks before surgery date for both groups. During the first week patients in group A (Wolffia Globosa) will be allowed to have two meals a day and one protein shake (Wolffia Globosa) of 16 oz. Each meal will consist of 3-5 oz of lean protein (Chicken, turkey or fish) and one cup of vegetables or salad. During the second week, patients will drink one protein shake of 16 oz (Wolffia Globosa) as a meal replacement, three times per day and will not be allowed to eat solid food. Patients will also be allowed to Drink clear liquids in between protein shakes. | Other: Dietary modification with introduction of Mankai<br>* 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.<br>|
| No Intervention: Control Group<br>The pre-operative liquid diet will be started two weeks before surgery date for both groups. During the first week patients in group B (Control) will be allowed to have two meals a day and one protein shake (Control) of 16 oz. Each meal will consist of 3-5 oz of lean protein (Chicken, turkey or fish) and one cup of vegetables or salad. During the second week, patients will drink one protein shake of 16 oz (Control) as a meal replacement, three times per day and will not be allowed to eat solid food. Patients will also be allowed to Drink clear liquids in between protein shakes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2.5 months | 
| Adverse effect by patient report and clinical follow up | Adverse effect patient report and clinical follow up | 2.5 months | 
| Fat% (via Bioelectrical Impedance) | Fat% (via Bioelectrical Impedance) | 2.5 months | 
| Fatty liver infiltration by Ultrasound | Fatty liver infiltration by Ultrasound | 2.5 months | 
| Patient's adherence by food diary | Patient's adherence by food diary | 2.5 months | 
| Satisfaction of Patients by specific questionnaire | Satisfaction of Patients. by specific questionnaire | 2.5 months | 
| Free Fat Mass (via Bioelectrical Impedance) | Free Fat Mass (via Bioelectrical Impedance) | 2.5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wolffia Globosa, Bariatric surgery, Sleeve gastrectomy, Preoperative diet, Hepatic steatosis, Hyperglycemia