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Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)

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ClinicalTrials.gov Identifier: NCT03147456
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: (Cubitan Protein, Nutricia, Netherlands). Dietary Supplement: (preOp, Nutricia, Netherlands). Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: 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.
Primary Purpose: Other
Official Title: Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rcts)
Actual Study Start Date : March 8, 2017
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).
Dietary Supplement: (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).
Dietary Supplement: (preOp, Nutricia, Netherlands).
contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes



Primary Outcome Measures :
  1. Measurement of changes in Body Weight [ Time Frame: 3 months ]
    Measurement of changes in Body Weight

  2. Measurement of changes in Muscle mass. [ Time Frame: 3 months ]
    Measurement of changes in Muscle mass.

  3. Measurement of changes in Fat mass. [ Time Frame: 3 months ]
    Measurement of changes in Muscle mass.


Secondary Outcome Measures :
  1. To assess the measurement on Protein [ Time Frame: 3 months ]
    To assess the measurement on Protein

  2. To assess the measurement on Vitamin B12 [ Time Frame: 3 months ]
    To assess the measurement on Vitamin B12

  3. To assess the measurement on Magnesium [ Time Frame: 3 months ]
    To assess the measurement on Magnesium

  4. To assess the Zinc level measurement [ Time Frame: 3 months ]
    To assess the Zinc level measurement



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Study participants must have the following criteria in order to participate in the trial:

  1. Qatari males or females.
  2. Aged between 18 and 60 year
  3. 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:

  1. Any Renal or liver disease because that will affect protein or albumin level in body.
  2. Past history of bariatric surgery
  3. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147456


Contacts
Contact: Sahar Dahawi Alshamari 66655122 Salshamari1@hamad.qa
Contact: Fahad Hanna 70561906

Locations
Qatar
sahar Dahawi Alshamari Recruiting
Doha, Qatar, 00974
Contact: fahad hanna    70561906      
Sponsors and Collaborators
Hamad Medical Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03147456     History of Changes
Other Study ID Numbers: 16433
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hamad Medical Corporation:
bariatric
obesity
protein supplements