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

NCT03147456 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-05-10

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

(Cubitan Protein, Nutricia, Netherlands).

Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient.

DIETARY_SUPPLEMENT

(preOp, Nutricia, Netherlands).

contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-08
Primary Completion
2017-08-01
Completion
2017-08-01

Countries

  • Qatar

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03147456 on ClinicalTrials.gov