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

May 9, 2017 updated by: Hamad Medical Corporation

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: fahad hanna
  • Phone Number: 70561906

Study Locations

  • Qatar
      • Doha, Qatar, 00974
        • Recruiting
        • sahar Dahawi Alshamari
        • Contact:
          • fahad hanna
          • Phone Number: 70561906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hamad Medical Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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Conditions

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