Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-05 @ 5:59 PM
Study NCT ID:
NCT03147456
Status:
UNKNOWN
Last Update Posted:
2017-05-10
First Post:
2017-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Investigators and researchers in this study will be blinded to the intervention, i.e. they will not be aware of who is on protein supplement and who is on placebo. Patients will also be blinded to the intervention, i.e. they will not know whether they are taking protein or zero protein supplement. For the blinding there will be a dietician who will assign the treatment and the control to patients as per the above randomization results. This dietician will also be responsible for filling the intervention \\& control ready-to-feed shakes into identical bottles labeled either A or B, the dietician will not have any other responsibility such as data entry or follow up of participants as this will be done by the PI and research team, he will only be responsible for the blinding process.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-09', 'studyFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of changes in Body Weight', 'timeFrame': '3 months', 'description': 'Measurement of changes in Body Weight'}, {'measure': 'Measurement of changes in Muscle mass.', 'timeFrame': '3 months', 'description': 'Measurement of changes in Muscle mass.'}, {'measure': 'Measurement of changes in Fat mass.', 'timeFrame': '3 months', 'description': 'Measurement of changes in Muscle mass.'}], 'secondaryOutcomes': [{'measure': 'To assess the measurement on Protein', 'timeFrame': '3 months', 'description': 'To assess the measurement on Protein'}, {'measure': 'To assess the measurement on Vitamin B12', 'timeFrame': '3 months', 'description': 'To assess the measurement on Vitamin B12'}, {'measure': 'To assess the measurement on Magnesium', 'timeFrame': '3 months', 'description': 'To assess the measurement on Magnesium'}, {'measure': 'To assess the Zinc level measurement', 'timeFrame': '3 months', 'description': 'To assess the Zinc level measurement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bariatric', 'obesity', 'protein supplements'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '29423219', 'type': 'DERIVED', 'citation': 'Al-Shamari SD, ElSherif MA, Hamid W, Hanna F. The effect of protein supplementation on body muscle mass and fat mass in post-bariatric surgery: a randomized controlled trial (RCT) study protocol. Arch Public Health. 2018 Jan 22;76:7. doi: 10.1186/s13690-017-0252-2. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'One of the most common post-operative deficiencies or complications of bariatric surgery is protein malnutrition. It may lead to many predicaments such as malnutrition, vitamin, micro- and macronutrient deficiencies that can lead to deleterious consequences. A protein-rich diet make a person feel satiety and thereby the consumption will be low in overall energy intake. The objectives of our study are. The aim of this study is to assess the effect of protein supplementation on changes in health parameters such as fat mass, muscle mass, weigh change, protein (total and albumin), Vit B12, Zinc and Magnesium, in Qatari patients post bariatric surgery. Our participants are Qatari aged 18-45 years males and females recruited from the bariatric surgery centers of 2 major HMC hospitals (HGH hospital) and will be randomized to receive either the protein supplement (treatment group) or a dietary advice (control group). All participants will be equally followed and monitored for 3 months and data on the above parameters will be collected, together with other population characteristics, at Baseline, 1 month and 3 month. Data will then be analyzed using the most up-to-date SPSS statistical package to assess the effect of protein supplementation on the parameters of interest. Statistical measures will be carefully chosen to properly assess the difference in the treatment (protein supplementation) effect compared with the control (Dietary advice). Investigators hypothesize that Patients receiving protein supplement (intervention group) Compared with patient not on protein supplement (placebo group) will maintain weight loss and other essential health parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nStudy participants must have the following criteria in order to participate in the trial:\n\n1. Qatari males or females.\n2. Aged between 18 and 60 year\n3. Based at the bariatric surgery list of HMC with their follow up scheduled be at HMC.\n\nExclusion Criteria:\n\nPatients will be excluded from participating in the trial if they have the following criteria:\n\n1. Any Renal or liver disease because that will affect protein or albumin level in body.\n2. Past history of bariatric surgery\n3. Patients will be further excluded after starting the trial if they fall into the following categories:\n\n * Subjects who did not take at least 80% of their intervention product amount per day, or\n * Subjects who did not comply with the treatment (or placebo) for more than 3 days per week.\n\nAlso, patients who refuse to participate \\& patients with baseline tests showing they are in need for protein supplements will be excluded from the study and given the needed protein supplements per the standard care.'}, 'identificationModule': {'nctId': 'NCT03147456', 'briefTitle': 'Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamad Medical Corporation'}, 'officialTitle': 'Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rcts)', 'orgStudyIdInfo': {'id': '16433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Patients will receive nutritional counseling by a bariatric dietitian in a routine round, aiming that they will know the post-surgery diet stages and to not develop any nutritional deficiencies.Before discharge from the hospital, patients will receive supplement and will be advised by the dietitian regarding its use (one can per day, over 3-5 intervals). Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient (Cubitan Protein, Nutricia, Netherlands).', 'interventionNames': ['Dietary Supplement: (Cubitan Protein, Nutricia, Netherlands).']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Patients will receive nutritional counseling by a bariatric dietitian in a routine round, aiming that they will know the post-surgery diet stages and to not develop any nutritional deficiencies. Before discharge from the hospital, patients will receive supplement and will be advised by the dietitian regarding its use (one can per day over 3-5 intervals).Following hospital discharge, Control patients will receive supplement contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes (preOp, Nutricia, Netherlands).', 'interventionNames': ['Dietary Supplement: (preOp, Nutricia, Netherlands).']}], 'interventions': [{'name': '(Cubitan Protein, Nutricia, Netherlands).', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient.', 'armGroupLabels': ['Intervention group']}, {'name': '(preOp, Nutricia, Netherlands).', 'type': 'DIETARY_SUPPLEMENT', 'description': 'contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00974', 'city': 'Doha', 'status': 'RECRUITING', 'country': 'Qatar', 'contacts': [{'name': 'fahad hanna', 'role': 'CONTACT', 'phone': '70561906'}], 'facility': 'sahar Dahawi Alshamari', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'centralContacts': [{'name': 'Sahar Dahawi Alshamari', 'role': 'CONTACT', 'email': 'Salshamari1@hamad.qa', 'phone': '66655122'}, {'name': 'Fahad Hanna', 'role': 'CONTACT', 'phone': '70561906'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}