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Effect of Protein Supplementation After Bariatric Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02001636
Acronym
EPEAB
Enrollment
35
Registered
2013-12-05
Start date
2011-11-30
Completion date
2012-12-31
Last updated
2013-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein Malnutrition

Keywords

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

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.

Interventions

DRUGResource Instant Protein 88

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

DRUGResource Maltodextrin

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

Sponsors

University of Hohenheim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Excess weight loss [%]At month 6

Secondary

MeasureTime frameDescription
Content of lean body mass in lost weight [%]At month 6Lean 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.

Other

MeasureTime frameDescription
Content of body fat in lost weight [%]At month 6Body 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026