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

NCT03999632 | Completed DMC

• 1 other identifier: FLA 18-070
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Bariatric Surgery Candidate; Diet Modification

Keywords

Bariatric surgery; Sleeve gastrectomy; Preoperative diet; Hepatic steatosis; Wolffia Globosa; Hyperglycemia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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

Study Arms (2)

Mankai Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Dietary modification with introduction of Mankai OTHER

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.

Mankai Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that will undergo sleeve gastrectomy.

You may not qualify if:

• Age below 18 years
• American Society of Anesthesiologist (ASA) class IV or V
• Patients using Vitamin-K antagonists
• Patients with documented coagulopathies.

Sponsors & Collaborators

• Cleveland Clinic Florida: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (12)

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  PMID: 23107545 BACKGROUND

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  PMID: 20479151 BACKGROUND

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MeSH Terms

Conditions

Fatty Liver; Hyperglycemia

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Emanuele Lo Menzo, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director Department of Research,

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: June 27, 2019
• Study Start: August 1, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)