Clinical trial NCT03999632: Effects of Wolffia Globosa (Mankai) in Patients Undergoing Bariatric Surgery.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bariatric Surgery Candidate
Diet Modification
Keywords: Bariatric surgery
Sleeve gastrectomy
Preoperative diet
Hepatic steatosis
Wolffia Globosa
Hyperglycemia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: OTHER

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

Eligibility 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.

Primary outcomes:
measure: Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE
timeFrame: 2 weeks
measure: Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis by fasting glucose and Hgb A1c
timeFrame: 2 weeks
measure: Patient's liking with Wolffia Globosa (Mankai) shake measured with a questionnaire
timeFrame: 2 weeks
measure: Patient's tolerance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
timeFrame: 2 weeks
measure: Patient's compliance with Wolffia Globosa (Mankai) shake. measured with a questionnaire
timeFrame: 2 weeks
Secondary outcomes:
measure: Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements
timeFrame: 2.5 months
measure: Adverse effect by patient report and clinical follow up
timeFrame: 2.5 months
measure: Fat% (via Bioelectrical Impedance)
timeFrame: 2.5 months
measure: Fatty liver infiltration by Ultrasound
timeFrame: 2.5 months
measure: Patient's adherence by food diary
timeFrame: 2.5 months
measure: Satisfaction of Patients by specific questionnaire
timeFrame: 2.5 months
measure: Free Fat Mass (via Bioelectrical Impedance)
timeFrame: 2.5 months
Other outcomes:
Locations:
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Cleveland Clinic Florida
name: Emanuele Lo Menzo, MD
role: PRINCIPAL_INVESTIGATOR
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