Clinical trial NCT03147456: Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rct)
Official title: Protein Supplementation Impact On Body Muscle Mass And Fat Mass In Qataris Post Bariatric Surgery, Randomized Controlled Trials (Rcts)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: bariatric
obesity
protein supplements
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Measurement of changes in Body Weight
timeFrame: 3 months
measure: Measurement of changes in Muscle mass.
timeFrame: 3 months
measure: Measurement of changes in Fat mass.
timeFrame: 3 months
Secondary outcomes:
measure: To assess the measurement on Protein
timeFrame: 3 months
measure: To assess the measurement on Vitamin B12
timeFrame: 3 months
measure: To assess the measurement on Magnesium
timeFrame: 3 months
measure: To assess the Zinc level measurement
timeFrame: 3 months
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: sahar Dahawi Alshamari
Study officials:
References:
citation: 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.