Effect of Protein Supplementation After Bariatric Surgery (EPEAB)

Impact of Protein Supplementation After Bariatric Surgery - a Randomized, Controlled, Double Blind Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Protein Malnutrition
• Intervention / Treatment: Drug: Resource Instant Protein 88; Drug: Resource Maltodextrin

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany, 72076
    • Department of General, Visceral and Transplant Surgery, University Hospital of Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Protein group; Patient group which takes daily protein supplements after bariatric surgery over 6 months. Protein product: Resource Instant Protein 88, Nestlé Health Nutrition	Drug: 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.
Placebo Comparator: 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	Drug: Resource Maltodextrin; Placebo product (Resource Maltodextrin, Nestlé Health Nutrition). Postoperative intake of 30 - 35 g powder per day over 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Excess weight loss [%]	At month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Content of lean body mass in lost weight [%]	Lean body mass is measured by using bioelectrical impedance analysis. The content of lean body mass in lost weight is calculated using the lost weight in kg and the lost lean body mass in kg.	At month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Content of body fat in lost weight [%]	Body fat mass is measured by using bioelectrical impedance analysis. The content of body fat mass in lost weight is calculated using the lost weight in kg and the lost body fat in kg.	At month 6

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Investigators: Principal Investigator: Stephan C Bischoff, Prof.Dr.med., Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (Estimate): December 5, 2013

Study Record Updates

• Last Update Posted (Estimate): December 5, 2013
• Last Update Submitted That Met QC Criteria: November 27, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Bariatric surgery; Body composition; Protein supplementation; Protein intake; Protein malnutrition; Body fat mass
• Additional Relevant MeSH Terms: Nutrition Disorders; Severe Acute Malnutrition; Malnutrition; Kwashiorkor
• Other Study ID Numbers: DONM-UHOH-386