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

Not Applicable

Completed

• Conditions: Bariatric Surgery Candidate; Diet Modification
• Interventions: Other: Dietary modification with introduction of Mankai

• Registration Number: NCT03999632
• Lead Sponsor: Cleveland Clinic Florida

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-27
• Study Start: 2019-08-01
• Primary Completion: 2020-10-01
• Study Completion: 2020-12-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mankai Group	Dietary modification with introduction of Mankai	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.

Primary Outcome Measures

Name	Time	Method
Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE	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	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	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	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	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

Secondary Outcome Measures

Name	Time	Method
Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements	2.5 months	Serum levels of the common nutritional parameters will be checked before and after the intervention
Adverse effect by patient report and clinical follow up	2.5 months	Adverse effect patient report and clinical follow up
Fat% (via Bioelectrical Impedance)	2.5 months	Fat% (via Bioelectrical Impedance)
Fatty liver infiltration by Ultrasound	2.5 months	Fatty liver infiltration by Ultrasound
Patient's adherence by food diary	2.5 months	Patient's adherence by food diary
Satisfaction of Patients by specific questionnaire	2.5 months	Satisfaction of Patients. by specific questionnaire
Free Fat Mass (via Bioelectrical Impedance)	2.5 months	Free Fat Mass (via Bioelectrical Impedance)

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States