Effect of Protein Supplementation After Bariatric Surgery

Protein Malnutrition Clinical Trial

— EPEAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001636
• Other study ID #: DONM-UHOH-386
• Status: Completed
• Phase: N/A
• First received: November 20, 2013
• Last updated: November 27, 2013
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Kwashiorkor
• Malnutrition
• Protein Malnutrition

Intervention

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

Locations

Country	Name	City	State
Germany	Department of General, Visceral and Transplant Surgery, University Hospital of Tübingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University of Hohenheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	Excess weight loss [%]		At month 6	Yes
Secondary	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	Yes