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

NCT ID: NCT03147456

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-08
• Study Completion Date: 2017-08-01

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: EXPERIMENTAL

(Cubitan Protein, Nutricia, Netherlands).

Intervention Type: DIETARY_SUPPLEMENT

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

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).

Group Type: PLACEBO_COMPARATOR

(preOp, Nutricia, Netherlands).

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

(Cubitan Protein, Nutricia, Netherlands).

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

Intervention Type: DIETARY_SUPPLEMENT

(preOp, Nutricia, Netherlands).

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

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

sahar Dahawi Alshamari

Doha, , Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Sahar Dahawi Alshamari

Role: CONTACT

Salshamari1@hamad.qa

66655122

Fahad Hanna

Role: CONTACT

70561906

Facility Contacts

fahad hanna

Role: primary

70561906

References

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.

Reference Type: DERIVED

PMID: 29423219 (View on PubMed)

Other Identifiers

16433

Identifier Type: -

Identifier Source: org_study_id