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)

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: Unknown
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: (Cubitan Protein, Nutricia, Netherlands).; Dietary supplement: (preOp, Nutricia, Netherlands).

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

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).	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

Outcome Measure	Measure Description	Time Frame
Measurement of changes in Body Weight	Measurement of changes in Body Weight	3 months
Measurement of changes in Muscle mass.	Measurement of changes in Muscle mass.	3 months
Measurement of changes in Fat mass.	Measurement of changes in Muscle mass.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the measurement on Protein	To assess the measurement on Protein	3 months
To assess the measurement on Vitamin B12	To assess the measurement on Vitamin B12	3 months
To assess the measurement on Magnesium	To assess the measurement on Magnesium	3 months
To assess the Zinc level measurement	To assess the Zinc level measurement	3 months

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 8, 2017
• Primary Completion (ANTICIPATED): August 1, 2017
• Study Completion (ANTICIPATED): August 1, 2017

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: obesity; bariatric; protein supplements
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID 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