Effect of Protein Supplementation After Bariatric Surgery

NCT ID: NCT02001636

Last Updated: 2013-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-12-31

Brief Summary

Obese patients, who underwent bariatric surgery, are at risk to develop protein malnutrition. The aim of this study is to evaluate the influence of postoperative protein supplementation on weight reduction, body composition and protein status.

Detailed Description

Bariatric surgery has become a major treatment option for severe obesity in adults. It has proven its efficiency regarding weight loss and its benefits concerning the improvement or even remission of obesity related comorbidities. Additionally, bariatric surgery procedures can be performed laparoscopically, which decreases the complication rate and reduces postoperative pains. Despite the advantages of bariatric surgery, attention needs to be paid to the possible risks following the surgical treatment. Postoperative risks often concern the nutritional status. It has been shown that, beside different micronutrient deficiencies, bariatric surgery also leads to an increased risk of developing protein malnutrition. Discussed reasons for this are the malabsorption of nutrients and the restricted food intake after surgery, which may lead to reduced protein consumption. Postoperative occurrence of vomiting or different food intolerances may support this effect. Accordingly, if an inadequate supply persists, a protein deficit will occur and this, in turn, may lead to an undesirable reduction in muscle mass and plasma protein levels. Based on this background, numerous studies indicate an increased incidence of protein malnutrition after bariatric surgery by detecting a decrease in levels of albumin and prealbumin, a significant reduction in lean body mass, as well as an inadequate protein intake after surgical treatment.

Dietary proteins have shown to play an important role in body weight regulation. There is evidence that a protein-rich diet is supposed to facilitate weight loss, to support successful weight maintenance, to attain satiety and to preserve lean body mass. Therefore, the use of protein supplements after bariatric surgery may minimize the risk for developing protein malnutrition and hence optimize the postoperative care.

The primary aim of this randomized, placebo-controlled, double blind pilot study was to evaluate the influence of postoperative protein supplementation on body weight reduction, body composition and protein status.

Conditions

Protein Malnutrition

Keywords

Bariatric surgery; Protein malnutrition; Protein supplementation; Body composition; Body fat mass; Protein intake

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Protein group

Patient group which takes daily protein supplements after bariatric surgery over 6 months.

Protein product: Resource Instant Protein 88, Nestlé Health Nutrition

Group Type: EXPERIMENTAL

Resource Instant Protein 88

Intervention Type: DRUG

Protein product: Resource Instant Protein 88, Nestlé Health Nutrition; postoperative intake of 30 - 35 g powder per day over 6 months.

Control group

Patient group which takes daily isocaloric placebo after bariatric surgery over 6 months and thus can be compared to the protein group.

Placebo product: Resource Maltodextrin, Nestlé Health Nutrition

Group Type: PLACEBO_COMPARATOR

Resource Maltodextrin

Intervention Type: DRUG

Placebo product (Resource Maltodextrin, Nestlé Health Nutrition). Postoperative intake of 30 - 35 g powder per day over 6 months.

Interventions

Resource Instant Protein 88

Protein product: Resource Instant Protein 88, Nestlé Health Nutrition; postoperative intake of 30 - 35 g powder per day over 6 months.

Intervention Type: DRUG

Resource Maltodextrin

Placebo product (Resource Maltodextrin, Nestlé Health Nutrition). Postoperative intake of 30 - 35 g powder per day over 6 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 65 years
• BMI of 35 kg/m2 or more
• Indication for laparoscopic sleeve gastrectomy or Roux-en Y gastric bypass

Exclusion Criteria

• Renal disease
• Type 2 diabetes

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hohenheim

OTHER

Sponsor Role: lead

Responsible Party

Stephan C. Bischoff, MD, Professor

Professor Dr. med. Stephan C. Bischoff

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan C Bischoff, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

Locations

Department of General, Visceral and Transplant Surgery, University Hospital of Tübingen

Tübingen, , Germany

Countries

Germany

Other Identifiers

DONM-UHOH-386

Identifier Type: -

Identifier Source: org_study_id