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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03147456
• Other study ID #: 16433
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2017
• Last updated: May 9, 2017
• Start date: March 8, 2017
• Est. completion date: August 1, 2017

Study information

• Verified date: March 2017
• Source: Hamad Medical Corporation
• Contact: Sahar Dahawi Alshamari
• Phone: 66655122
• Email: Salshamari1[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• (Cubitan Protein, Nutricia, Netherlands).
Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient.
• (preOp, Nutricia, Netherlands).
contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes

Locations

Country	Name	City	State
Qatar	sahar Dahawi Alshamari	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of changes in Body Weight	Measurement of changes in Body Weight	3 months
Primary	Measurement of changes in Muscle mass.	Measurement of changes in Muscle mass.	3 months
Primary	Measurement of changes in Fat mass.	Measurement of changes in Muscle mass.	3 months
Secondary	To assess the measurement on Protein	To assess the measurement on Protein	3 months
Secondary	To assess the measurement on Vitamin B12	To assess the measurement on Vitamin B12	3 months
Secondary	To assess the measurement on Magnesium	To assess the measurement on Magnesium	3 months
Secondary	To assess the Zinc level measurement	To assess the Zinc level measurement	3 months