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Effect of Protein Supplementation After Bariatric Surgery (EPEAB)

Primary Purpose

Protein Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Resource Instant Protein 88
Resource Maltodextrin
Sponsored by
University of Hohenheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Protein Malnutrition focused on measuring Bariatric surgery, Protein malnutrition, Protein supplementation, Body composition, Body fat mass, Protein intake

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Protein group

Control group

Arm Description

Patient group which takes daily protein supplements after bariatric surgery over 6 months. Protein product: Resource Instant Protein 88, Nestlé Health Nutrition

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

Outcomes

Primary Outcome Measures

Excess weight loss [%]

Secondary Outcome Measures

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.

Full Information

First Posted
November 20, 2013
Last Updated
November 27, 2013
Sponsor
University of Hohenheim
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1. Study Identification

Unique Protocol Identification Number
NCT02001636
Brief Title
Effect of Protein Supplementation After Bariatric Surgery
Acronym
EPEAB
Official Title
Impact of Protein Supplementation After Bariatric Surgery - a Randomized, Controlled, Double Blind Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hohenheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protein Malnutrition
Keywords
Bariatric surgery, Protein malnutrition, Protein supplementation, Body composition, Body fat mass, Protein intake

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Protein group
Arm Type
Experimental
Arm Description
Patient group which takes daily protein supplements after bariatric surgery over 6 months. Protein product: Resource Instant Protein 88, Nestlé Health Nutrition
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Resource Instant Protein 88
Intervention Description
Protein product: Resource Instant Protein 88, Nestlé Health Nutrition; postoperative intake of 30 - 35 g powder per day over 6 months.
Intervention Type
Drug
Intervention Name(s)
Resource Maltodextrin
Intervention Description
Placebo product (Resource Maltodextrin, Nestlé Health Nutrition). Postoperative intake of 30 - 35 g powder per day over 6 months.
Primary Outcome Measure Information:
Title
Excess weight loss [%]
Time Frame
At month 6
Secondary Outcome Measure Information:
Title
Content of lean body mass in lost weight [%]
Description
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.
Time Frame
At month 6
Other Pre-specified Outcome Measures:
Title
Content of body fat in lost weight [%]
Description
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.
Time Frame
At month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan C Bischoff, Prof.Dr.med.
Organizational Affiliation
Department of Nutritional Medicine, University of Hohenheim, Stuttgart, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General, Visceral and Transplant Surgery, University Hospital of Tübingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

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Effect of Protein Supplementation After Bariatric Surgery

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