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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03999632
Recruitment Status : Recruiting
First Posted : June 27, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Emanuele LoMenzo, 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


Condition or disease Intervention/treatment Phase
Bariatric Surgery Candidate Diet Modification Other: Dietary modification with introduction of Mankai Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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.
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mankai Group
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
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.

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE [ Time Frame: 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

  2. Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis by fasting glucose and Hgb A1c [ Time Frame: 2 weeks ]
    Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis (T2DM). measure by fasting glucose and Hgb A1c

  3. Patient's liking with Wolffia Globosa (Mankai) shake measured with a questionnaire [ Time Frame: 2 weeks ]
    Patient's liking with Wolffia Globosa (Mankai) shake. measured with a questionnaire

  4. Patient's tolerance with Wolffia Globosa (Mankai) shake. measured with a questionnaire [ Time Frame: 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

  5. Patient's compliance with Wolffia Globosa (Mankai) shake. measured with a questionnaire [ Time Frame: 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 :
  1. Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements [ Time Frame: 2.5 months ]
    Serum levels of the common nutritional parameters will be checked before and after the intervention

  2. Adverse effect by patient report and clinical follow up [ Time Frame: 2.5 months ]
    Adverse effect patient report and clinical follow up

  3. Fat% (via Bioelectrical Impedance) [ Time Frame: 2.5 months ]
    Fat% (via Bioelectrical Impedance)

  4. Fatty liver infiltration by Ultrasound [ Time Frame: 2.5 months ]
    Fatty liver infiltration by Ultrasound

  5. Patient's adherence by food diary [ Time Frame: 2.5 months ]
    Patient's adherence by food diary

  6. Satisfaction of Patients by specific questionnaire [ Time Frame: 2.5 months ]
    Satisfaction of Patients. by specific questionnaire

  7. Free Fat Mass (via Bioelectrical Impedance) [ Time Frame: 2.5 months ]
    Free Fat Mass (via Bioelectrical Impedance)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03999632


Contacts
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Contact: Emanuele Lo Menzo, MD 9546595232 lomenze@ccf.org

Locations
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United States, Florida
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Sponsors and Collaborators
Cleveland Clinic Florida
Investigators
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Principal Investigator: Emanuele Lo Menzo, MD Cleveland Clinic Florida

Publications:

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Responsible Party: Emanuele LoMenzo, Principal Investigator, Director Department of Research,, Cleveland Clinic Florida
ClinicalTrials.gov Identifier: NCT03999632    
Other Study ID Numbers: FLA 18-070
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Confidentiality and Privacy:

Information about study subjects will be kept confidential and managed according to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Source Documents:

Source data will include the electronic health record for patient demographics, vitals, and basic laboratory results. Dictated operative notes will be maintained within the EHR as well. Lab results of inflammatory markers will be kept out of the EHR and kept in a secure file on the Cleveland Clinic server.

Records Retention:

The investigators will retain study essential documents for at least six years after completion of the research and are accessible for inspection by authorized representatives at reasonable times and in a reasonable manner.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emanuele LoMenzo, Cleveland Clinic Florida:
Bariatric surgery
Sleeve gastrectomy
Preoperative diet
Hepatic steatosis
Wolffia Globosa
Hyperglycemia