Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-30 @ 10:25 PM
Study NCT ID:
NCT03999632
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2019-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Wolffia Globosa (Mankai) in Patients Undergoing Bariatric Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2019-04-17', 'studyFirstSubmitQcDate': '2019-06-25', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patient's Satiety with Wolffia Globosa (Mankai) shake measured with a QUALITY OF ALIMENTATION QUESTIONNAIRE", 'timeFrame': '2 weeks', 'description': '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'}, {'measure': 'Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis by fasting glucose and Hgb A1c', 'timeFrame': '2 weeks', 'description': 'Glucose control in patients with previous Type 2 Diabetes Mellitus diagnosis (T2DM). measure by fasting glucose and Hgb A1c'}, {'measure': "Patient's liking with Wolffia Globosa (Mankai) shake measured with a questionnaire", 'timeFrame': '2 weeks', 'description': "Patient's liking with Wolffia Globosa (Mankai) shake. measured with a questionnaire"}, {'measure': "Patient's tolerance with Wolffia Globosa (Mankai) shake. measured with a questionnaire", 'timeFrame': '2 weeks', 'description': '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'}, {'measure': "Patient's compliance with Wolffia Globosa (Mankai) shake. measured with a questionnaire", 'timeFrame': '2 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Metabolic and nutritional effects of Wolffia Globosa (Mankai) in patients undergoing bariatric surgery by serum measurements', 'timeFrame': '2.5 months', 'description': 'Serum levels of the common nutritional parameters will be checked before and after the intervention'}, {'measure': 'Adverse effect by patient report and clinical follow up', 'timeFrame': '2.5 months', 'description': 'Adverse effect patient report and clinical follow up'}, {'measure': 'Fat% (via Bioelectrical Impedance)', 'timeFrame': '2.5 months', 'description': 'Fat% (via Bioelectrical Impedance)'}, {'measure': 'Fatty liver infiltration by Ultrasound', 'timeFrame': '2.5 months', 'description': 'Fatty liver infiltration by Ultrasound'}, {'measure': "Patient's adherence by food diary", 'timeFrame': '2.5 months', 'description': "Patient's adherence by food diary"}, {'measure': 'Satisfaction of Patients by specific questionnaire', 'timeFrame': '2.5 months', 'description': 'Satisfaction of Patients. by specific questionnaire'}, {'measure': 'Free Fat Mass (via Bioelectrical Impedance)', 'timeFrame': '2.5 months', 'description': 'Free Fat Mass (via Bioelectrical Impedance)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Sleeve gastrectomy', 'Preoperative diet', 'Hepatic steatosis', 'Wolffia Globosa', 'Hyperglycemia'], 'conditions': ['Bariatric Surgery Candidate', 'Diet Modification']}, 'referencesModule': {'references': [{'pmid': '16001874', 'type': 'BACKGROUND', '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.'}, {'pmid': '23107545', 'type': 'BACKGROUND', '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.'}, {'pmid': '22412075', 'type': 'BACKGROUND', '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.'}, {'pmid': '28122929', 'type': 'BACKGROUND', 'citation': 'Chalvon-Demersay T, Azzout-Marniche D, Arfsten J, Egli L, Gaudichon C, Karagounis LG, Tome 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.'}, {'pmid': '20479151', 'type': 'BACKGROUND', '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.'}, {'pmid': '26143683', 'type': 'BACKGROUND', '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.'}, {'pmid': '21831992', 'type': 'BACKGROUND', '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.'}, {'pmid': '27022032', 'type': 'BACKGROUND', '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.'}, {'pmid': '27479196', 'type': 'BACKGROUND', '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.'}, {'pmid': '28111625', 'type': 'BACKGROUND', '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.'}, {'pmid': '27493937', 'type': 'BACKGROUND', '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.'}, {'pmid': '27916823', 'type': 'BACKGROUND', 'citation': 'Rizzo G, Lagana 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):767. doi: 10.3390/nu8120767.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Patients that will undergo sleeve gastrectomy.\n\nExclusion Criteria:\n\n* Age below 18 years\n* American Society of Anesthesiologist (ASA) class IV or V\n* Patients using Vitamin-K antagonists\n* Patients with documented coagulopathies.'}, 'identificationModule': {'nctId': 'NCT03999632', 'briefTitle': 'Effects of Wolffia Globosa (Mankai) in Patients Undergoing Bariatric Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': "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.", 'orgStudyIdInfo': {'id': 'FLA 18-070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mankai Group', 'description': '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.', 'interventionNames': ['Other: Dietary modification with introduction of Mankai']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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': [{'name': 'Dietary modification with introduction of Mankai', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Mankai Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}], 'overallOfficials': [{'name': 'Emanuele Lo Menzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cleveland Clinic Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Confidentiality and Privacy:\n\nInformation about study subjects will be kept confidential and managed according to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).\n\nSource Documents:\n\nSource data will include the electronic health record for patient demographics, vitals, and basic laboratory results. Dictated operative notes will be maintained within the EHR as well. Lab results of inflammatory markers will be kept out of the EHR and kept in a secure file on the Cleveland Clinic server.\n\nRecords Retention:\n\nThe investigators will retain study essential documents for at least six years after completion of the research and are accessible for inspection by authorized representatives at reasonable times and in a reasonable manner.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cleveland Clinic Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Director Department of Research,', 'investigatorFullName': 'Emanuele LoMenzo', 'investigatorAffiliation': 'Cleveland Clinic Florida'}}}}