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Completed

NCT Number: NCT03999632

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

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

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Key information

Conditions

Bariatric Surgery Candidate Diet Modification Digestive System Diseases Fatty Liver Glucose Metabolism Disorders Hyperglycemia Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Cleveland Clinic Florida

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2019
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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