Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-25 @ 6:42 PM
Study NCT ID:
NCT02919657
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2016-09-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Absorption Comparison on Equivalency Value of Genepro Gen2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dmichael@medfitrx.net', 'phone': '9196109893', 'title': 'David Michael', 'organization': 'Medfit Rx'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'No adverse events were monitored', 'eventGroups': [{'id': 'EG000', 'title': 'Genepro Gen2 Protein', 'description': '1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.\n\nIntervention: Weekly blood draws will determine the effect on blood protein levels.\n\nGenepro Protein: weekly blood draws to measure blood protein levels', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Whey Protein Isolate', 'description': '30g Serving of Whey Isolate Protein will be used daily in each subject.\n\nIntervention: Weekly blood draws will determine the effect on blood protein levels.\n\nWhey Protein: weekly blood draws to measure blood protein levels', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Weekly Blood Draws to Measure Blood Protein Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Genepro Gen2 Protein', 'description': '1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.\n\nIntervention: Weekly blood draws will determine the effect on blood protein levels.\n\nGenepro Protein: weekly blood draws to measure blood protein levels'}, {'id': 'OG001', 'title': 'Whey Protein Isolate', 'description': '30g Serving of Whey Isolate Protein will be used daily in each subject.\n\nIntervention: Weekly blood draws will determine the effect on blood protein levels.\n\nWhey Protein: weekly blood draws to measure blood protein levels'}], 'classes': [{'title': 'Female Age 37', 'categories': [{'measurements': [{'value': '7.23', 'spread': '.4', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '.4', 'groupId': 'OG001'}]}]}, {'title': 'Male Age 34', 'categories': [{'measurements': [{'value': '7.43', 'spread': '.7', 'groupId': 'OG000'}, {'value': '7.21', 'spread': '.3', 'groupId': 'OG001'}]}]}, {'title': 'Male Age 30', 'categories': [{'measurements': [{'value': '7.1', 'spread': '.5', 'groupId': 'OG000'}, {'value': '7.28', 'spread': '.2', 'groupId': 'OG001'}]}]}, {'title': 'Female Age 32', 'categories': [{'measurements': [{'value': '7.16', 'spread': '.3', 'groupId': 'OG000'}, {'value': '6.95', 'spread': '.1', 'groupId': 'OG001'}]}]}, {'title': 'Female Age 40', 'categories': [{'measurements': [{'value': '7.2', 'spread': '.3', 'groupId': 'OG000'}, {'value': '6.86', 'spread': '.2', 'groupId': 'OG001'}]}]}, {'title': 'Male Age 40', 'categories': [{'measurements': [{'value': '7.11', 'spread': '.8', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Male B Age 34', 'categories': [{'measurements': [{'value': '7.05', 'spread': '.6', 'groupId': 'OG000'}, {'value': '6.95', 'spread': '.5', 'groupId': 'OG001'}]}]}, {'title': 'Female Age 34', 'categories': [{'measurements': [{'value': '6.6', 'spread': '.2', 'groupId': 'OG000'}, {'value': '6.46', 'spread': '.3', 'groupId': 'OG001'}]}]}, {'title': 'Female B Age 37', 'categories': [{'measurements': [{'value': '6.55', 'spread': '.2', 'groupId': 'OG000'}, {'value': '6.65', 'spread': '.2', 'groupId': 'OG001'}]}]}, {'title': 'Male Age 39', 'categories': [{'measurements': [{'value': '7.18', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '.3', 'groupId': 'OG001'}]}]}, {'title': 'Female Age 30', 'categories': [{'measurements': [{'value': '6.81', 'spread': '.5', 'groupId': 'OG000'}, {'value': '6.58', 'spread': '.2', 'groupId': 'OG001'}]}]}, {'title': 'Male Age 46', 'categories': [{'measurements': [{'value': '6.81', 'spread': '.5', 'groupId': 'OG000'}, {'value': '6.58', 'spread': '.2', 'groupId': 'OG001'}]}]}, {'title': 'Female Age 39', 'categories': [{'measurements': [{'value': '6.76', 'spread': '.3', 'groupId': 'OG000'}, {'value': '6.03', 'spread': '.5', 'groupId': 'OG001'}]}]}, {'title': 'Male Age 36', 'categories': [{'measurements': [{'value': '6.81', 'spread': '.5', 'groupId': 'OG000'}, {'value': '6.48', 'spread': '.2', 'groupId': 'OG001'}]}]}, {'title': 'Female B Age 32', 'categories': [{'measurements': [{'value': '6.88', 'spread': '.6', 'groupId': 'OG000'}, {'value': '6.26', 'spread': '.4', 'groupId': 'OG001'}]}]}, {'title': 'Male Age 38', 'categories': [{'measurements': [{'value': '7.18', 'spread': '.5', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '.8', 'groupId': 'OG001'}]}]}, {'title': 'Female Age 36', 'categories': [{'measurements': [{'value': '6.73', 'spread': '.9', 'groupId': 'OG000'}, {'value': '6.31', 'spread': '.4', 'groupId': 'OG001'}]}]}, {'title': 'Male C Age 34', 'categories': [{'measurements': [{'value': '7.13', 'spread': '.4', 'groupId': 'OG000'}, {'value': '7', 'spread': '.4', 'groupId': 'OG001'}]}]}, {'title': 'Female B Age 36', 'categories': [{'measurements': [{'value': '6.13', 'spread': '.8', 'groupId': 'OG000'}, {'value': '6', 'spread': '.8', 'groupId': 'OG001'}]}]}, {'title': 'Male Age 41', 'categories': [{'measurements': [{'value': '7', 'spread': '.5', 'groupId': 'OG000'}, {'value': '6.95', 'spread': '.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks per intervention', 'description': 'Each week the 20 participants will have blood drawn to measure their blood protein levels.\n\nEach participant was required to give blood weekly to determine the blood protein levels. The results show the average over each six week period of testing for each row. Each participant was examined to see if they achieved the average range as set fourth by the dieticians of greater than 6.1 and less than 8.7 within a 10% variable as acceptable.\n\n10 Participants will be given Genepro Gen2 for the first six weeks of the study and whey protein for the final 6.\n\n10 Participants will be given when protein for the first six weeks of the study and Genepro Gen2 for the final 6.\n\nThese measurements will read in g/dl', 'unitOfMeasure': 'grams per deciliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Genepro Gen2 Protein Then Whey Protein', 'description': '1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.\n\n30g Serving of Whey Isolate Protein will be used daily in each subject.'}, {'id': 'FG001', 'title': 'Whey Protein Isolate Then Genepro Gen2 Protein', 'description': '30g Serving of Whey Isolate Protein will be used daily in each subject.\n\n1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '10 Participants', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': '10 Participants', 'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'completed with the same initial 10 participants', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': 'completed with the same initial 10 participants', 'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Open call for bariatric patients via social media and direct mail marketing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All participants were given a baseline blood analysis'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Protein blood levels', 'classes': [{'title': 'Genepro Gen2 first', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '.4', 'groupId': 'BG000'}]}]}, {'title': 'Whey Isolate first', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '.4', 'groupId': 'BG000'}]}]}, {'title': 'All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants assessed separately for each sequence.'}], 'populationDescription': '20 Post Op Gastric Bypass patients. 10 men, 10 women. All participants were between the ages of 30-46 years of age. All participants have been post operation from their weight loss surgery for a minimum of 3 months prior to the start of the study and no longer than 12 months at the start of the study.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-23', 'studyFirstSubmitDate': '2016-09-19', 'resultsFirstSubmitDate': '2016-10-04', 'studyFirstSubmitQcDate': '2016-09-28', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-30', 'studyFirstPostDateStruct': {'date': '2016-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly Blood Draws to Measure Blood Protein Levels', 'timeFrame': '6 weeks per intervention', 'description': 'Each week the 20 participants will have blood drawn to measure their blood protein levels.\n\nEach participant was required to give blood weekly to determine the blood protein levels. The results show the average over each six week period of testing for each row. Each participant was examined to see if they achieved the average range as set fourth by the dieticians of greater than 6.1 and less than 8.7 within a 10% variable as acceptable.\n\n10 Participants will be given Genepro Gen2 for the first six weeks of the study and whey protein for the final 6.\n\n10 Participants will be given when protein for the first six weeks of the study and Genepro Gen2 for the final 6.\n\nThese measurements will read in g/dl'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Analysis, Event History', 'Absorption; Disorder, Protein']}, 'descriptionModule': {'briefSummary': 'Genepro Gen2 Absorption and Protein Value Clinical Trial.', 'detailedDescription': 'Objective: To prove the absorbability and usability of Genepro Gen2 Protein and compared to whey isolate. This study is intended to show the equivalent value of Genepro Gen2 as compared to whey protein isolate (1 tablespoon Genepro Gen2 compared to 30g serving of whey isolate)\n\nParameters: This study encompasses a 12-week program that follows 20 gastric bypass patients that have undergone weight loss surgery. We took a baseline blood analysis prior to the start of the study and subsequently we took weekly blood work to chart and register the findings. For this study we will only be doing the weekly analysis on blood protein levels by utilizing Spectrophotometry. The target blood protein range is 6.1-8.7 g/dL this test is administered while fasting.\n\nParticipants: 20 Post Op Gastric Bypass patients. 10 men, 10 women. All participants were between the ages of 30-46 years of age. All participants have been post operation from their weight loss surgery for a minimum of 3 months prior to the start of the study and no longer than 12 months at the start of the study.\n\nGathering Results: 10 subjects will receive Genepro Gen 2 protein (1 tablespoon serving) for the first 6 weeks of the study and for the last six weeks, they will receive 30g of Whey protein. In conjunction the other group of 10 subjects will receive 30g whey protein the first 6 weeks of the study and Genepro Gen2 protein the final six weeks. Weekly blood analysis will determine blood protein levels.\n\nDiet: Diet guidelines limit the calories you consume while providing you with balanced meals to help prevent nutritional deficiencies and preserve your muscle tissue. Each patient tolerates suggested foods differently.\n\nDaily calories should be between 600 to 700 for the duration of this study. Each subject is to follow a diet low in calories, fats and sweets. The goal for each subject is to consume a minimum of 65 to 75 grams of protein a day. High protein foods include eggs, meats, fish, seafood, tuna, poultry, tofu, milk, soy, cottage cheese, and yogurt. 30g of each daily intake of protein will be provided by a powdered protein supplement. Each subject will utilize a 30g serving of whey isolate for 6 weeks of their study and for the other 6 weeks the subject will use a single serving (1tablespoon) of Genepro Gen2 Protein.\n\nSubject were given the following eating guidelines:\n\n* Eat slowly and chew small bites of food thoroughly.\n* Avoid rice, bread, raw vegetables, fresh fruits, and meats that are not easily chewed such as pork and steak. Ground meats are usually better tolerated.\n* With soft and solid foods, take only three bites at one sitting, then wait a minimum of 20 minutes before eating more.\n* Eat balanced meals with small portions.\n* Avoid the use of drinking straws and carbonated beverages, chewing gum and ice because they can introduce too much air into your pouch and cause discomfort.\n* Avoid sugar, sugar-containing foods and beverages, concentrated sweets, and fruit juices Alcoholic beverages will have a more profound effect and should be avoided or consumed with caution.\n\nExercise: Each subject is asked to exercise for 30 to 45 minutes a day, with cardio or aerobic activity three to five times a week. Initially, we recommend walking five minutes in the morning and five minutes in the late afternoon. As tolerated you should increase these intervals by five minutes until you are walking at least 15 minutes twice per day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '46 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '* 20 Post Op Gastric Bypass patients.\n* 10 men,\n* 10 women.\n* Minimum age 30\n* Maximum age 46\n* All participants have been post operation from their weight loss surgery for a minimum of 3 months prior to the start of the study and no longer than 12 months at the start of the study.\n\nExclusion Criteria:\n\n* Any digestive distress disorder (IBS, Crones, etc).'}, 'identificationModule': {'nctId': 'NCT02919657', 'briefTitle': 'Absorption Comparison on Equivalency Value of Genepro Gen2', 'organization': {'class': 'OTHER', 'fullName': 'Musclegen Research, Inc.'}, 'officialTitle': 'Genepro Gen2 Equivalency Study as Compared to Whey Isolate (1 Tablespoon of Genepro Gen2 and 30g Whey Isolate.', 'orgStudyIdInfo': {'id': 'Genepro Gen 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Genepro Gen2 Protein', 'description': '1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.\n\nIntervention: Weekly blood draws will determine the effect on blood protein levels.', 'interventionNames': ['Dietary Supplement: Genepro Protein']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whey Protein Isolate', 'description': '30g Serving of Whey Isolate Protein will be used daily in each subject.\n\nIntervention: Weekly blood draws will determine the effect on blood protein levels.', 'interventionNames': ['Dietary Supplement: Whey Protein']}], 'interventions': [{'name': 'Genepro Protein', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Genepro'], 'description': 'weekly blood draws to measure blood protein levels', 'armGroupLabels': ['Genepro Gen2 Protein']}, {'name': 'Whey Protein', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Whey Protein Isolate'], 'description': 'weekly blood draws to measure blood protein levels', 'armGroupLabels': ['Whey Protein Isolate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Michael, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Musclegen Research, Inc.'}, {'name': 'Brian M Parks, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedFit Rx, Inc.'}, {'name': 'Tony R Parks, BS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MedFit Rx, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '10 subjects will be administered genepro for the first 6 weeks of the study and whey protein the last 6 week. The other 10 subjects will be administered whey protein for the first 6 weeks of the study and Genepro Gen2 for the last 6 weeks. Weekly blood draws will be taken from each subject to analyze blood protein levels.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Musclegen Research, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}