Bariatric Surgery Candidate, Diet Modification
Conditions
Keywords
Bariatric surgery, Sleeve gastrectomy, Preoperative diet, Hepatic steatosis, Wolffia Globosa, Hyperglycemia
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
Interventions
OTHERDietary 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.
Sponsors
Cleveland Clinic Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of Patients by specific questionnaire | 2.5 months | Satisfaction of Patients. by specific questionnaire |
| 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 |
| Free Fat Mass (via Bioelectrical Impedance) | 2.5 months | Free Fat Mass (via Bioelectrical Impedance) |
| 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 |
Countries
United States
Outcome results
None listed