- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03147456
Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)
Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rcts)
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sahar Dahawi Alshamari
- Phone Number: 66655122
- Email: Salshamari1@hamad.qa
Study Contact Backup
- Name: fahad hanna
- Phone Number: 70561906
Study Locations
-
-
-
Doha, Qatar, 00974
- Recruiting
- sahar Dahawi Alshamari
-
Contact:
- fahad hanna
- Phone Number: 70561906
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Study participants must have the following criteria in order to participate in the trial:
- Qatari males or females.
- Aged between 18 and 60 year
- Based at the bariatric surgery list of HMC with their follow up scheduled be at HMC.
Exclusion Criteria:
Patients will be excluded from participating in the trial if they have the following criteria:
- Any Renal or liver disease because that will affect protein or albumin level in body.
- Past history of bariatric surgery
Patients will be further excluded after starting the trial if they fall into the following categories:
- Subjects who did not take at least 80% of their intervention product amount per day, or
- Subjects who did not comply with the treatment (or placebo) for more than 3 days per week.
Also, 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention group
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).
|
Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient.
|
PLACEBO_COMPARATOR: Control group
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).
|
contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of changes in Body Weight
Time Frame: 3 months
|
Measurement of changes in Body Weight
|
3 months
|
Measurement of changes in Muscle mass.
Time Frame: 3 months
|
Measurement of changes in Muscle mass.
|
3 months
|
Measurement of changes in Fat mass.
Time Frame: 3 months
|
Measurement of changes in Muscle mass.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the measurement on Protein
Time Frame: 3 months
|
To assess the measurement on Protein
|
3 months
|
To assess the measurement on Vitamin B12
Time Frame: 3 months
|
To assess the measurement on Vitamin B12
|
3 months
|
To assess the measurement on Magnesium
Time Frame: 3 months
|
To assess the measurement on Magnesium
|
3 months
|
To assess the Zinc level measurement
Time Frame: 3 months
|
To assess the Zinc level measurement
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16433
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on (Cubitan Protein, Nutricia, Netherlands).
-
Maastricht University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
UMC UtrechtUnknown
-
Medical University of GdanskNot yet recruitingGastric Cancer | Colorectal Cancer
-
Azienda Ospedaliero Universitaria Maggiore della...Nutricia, Inc.Completed
-
Jagiellonian UniversityCompletedPancreatic FistulaPoland
-
King's College Hospital NHS TrustKing's College LondonCompletedDiabetes | Chronic Kidney Disease | End Stage Renal Failure on DialysisUnited Kingdom
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedMultiple Myeloma | Waldenstrom Macroglobulinemia | Leukemia, Lymphocytic, Chronic, B-Cell | Leukemia, Hairy Cell | Lymphoma, Mantle-cellUnited States
-
Onconova Therapeutics, Inc.CompletedAdvanced Solid Tumor | HepatomaUnited States