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

Bariatric Surgery Candidate Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03999632
• Other study ID #: FLA 18-070
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Diet Modification

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Clinic Florida

Country where clinical trial is conducted

United States, 

References & Publications (12)

Chalvon-Demersay T, Azzout-Marniche D, Arfsten J, Egli L, Gaudichon C, Karagounis LG, Tomé D. A Systematic Review of the Effects of Plant Compared with Animal Protein Sources on Features of Metabolic Syndrome. J Nutr. 2017 Mar;147(3):281-292. doi: 10.3945/jn.116.239574. Epub 2017 Jan 25. Review. — View Citation

Derbyshire EJ. Flexitarian Diets and Health: A Review of the Evidence-Based Literature. Front Nutr. 2017 Jan 6;3:55. doi: 10.3389/fnut.2016.00055. eCollection 2016. Review. — View Citation

Edelman M, Colt M. Nutrient Value of Leaf vs. Seed. Front Chem. 2016 Jul 21;4:32. doi: 10.3389/fchem.2016.00032. eCollection 2016. — View Citation

Gilani GS, Cockell KA, Sepehr E. Effects of antinutritional factors on protein digestibility and amino acid availability in foods. J AOAC Int. 2005 May-Jun;88(3):967-87. Review. — View Citation

Malik VS, Li Y, Tobias DK, Pan A, Hu FB. Dietary Protein Intake and Risk of Type 2 Diabetes in US Men and Women. Am J Epidemiol. 2016 Apr 15;183(8):715-28. doi: 10.1093/aje/kwv268. Epub 2016 Mar 28. — View Citation

Micha R, Wallace SK, Mozaffarian D. Red and processed meat consumption and risk of incident coronary heart disease, stroke, and diabetes mellitus: a systematic review and meta-analysis. Circulation. 2010 Jun 1;121(21):2271-83. doi: 10.1161/CIRCULATIONAHA.109.924977. Epub 2010 May 17. Review. — View Citation

Pan A, Sun Q, Bernstein AM, Schulze MB, Manson JE, Stampfer MJ, Willett WC, Hu FB. Red meat consumption and mortality: results from 2 prospective cohort studies. Arch Intern Med. 2012 Apr 9;172(7):555-63. doi: 10.1001/archinternmed.2011.2287. Epub 2012 Mar 12. — View Citation

Pan A, Sun Q, Bernstein AM, Schulze MB, Manson JE, Willett WC, Hu FB. Red meat consumption and risk of type 2 diabetes: 3 cohorts of US adults and an updated meta-analysis. Am J Clin Nutr. 2011 Oct;94(4):1088-96. doi: 10.3945/ajcn.111.018978. Epub 2011 Aug 10. — View Citation

Rizzo G, Laganà AS, Rapisarda AM, La Ferrera GM, Buscema M, Rossetti P, Nigro A, Muscia V, Valenti G, Sapia F, Sarpietro G, Zigarelli M, Vitale SG. Vitamin B12 among Vegetarians: Status, Assessment and Supplementation. Nutrients. 2016 Nov 29;8(12). pii: E767. Review. — View Citation

Sarwar Gilani G, Wu Xiao C, Cockell KA. Impact of antinutritional factors in food proteins on the digestibility of protein and the bioavailability of amino acids and on protein quality. Br J Nutr. 2012 Aug;108 Suppl 2:S315-32. doi: 10.1017/S0007114512002371. Review. — View Citation

Song M, Fung TT, Hu FB, Willett WC, Longo VD, Chan AT, Giovannucci EL. Association of Animal and Plant Protein Intake With All-Cause and Cause-Specific Mortality. JAMA Intern Med. 2016 Oct 1;176(10):1453-1463. doi: 10.1001/jamainternmed.2016.4182. Erratum in: JAMA Intern Med. 2016 Nov 1;176(11):1728. — View Citation

Wang X, Lin X, Ouyang YY, Liu J, Zhao G, Pan A, Hu FB. Red and processed meat consumption and mortality: dose-response meta-analysis of prospective cohort studies. Public Health Nutr. 2016 Apr;19(5):893-905. doi: 10.1017/S1368980015002062. Epub 2015 Jul 6. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements	Serum levels of the common nutritional parameters will be checked before and after the intervention	2.5 months
Secondary	Adverse effect by patient report and clinical follow up	Adverse effect patient report and clinical follow up	2.5 months
Secondary	Fat% (via Bioelectrical Impedance)	Fat% (via Bioelectrical Impedance)	2.5 months
Secondary	Fatty liver infiltration by Ultrasound	Fatty liver infiltration by Ultrasound	2.5 months
Secondary	Patient's adherence by food diary	Patient's adherence by food diary	2.5 months
Secondary	Satisfaction of Patients by specific questionnaire	Satisfaction of Patients. by specific questionnaire	2.5 months
Secondary	Free Fat Mass (via Bioelectrical Impedance)	Free Fat Mass (via Bioelectrical Impedance)	2.5 months