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Effect of Protein Supplementation After Bariatric Surgery

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ToestandVoltooid
Sponsors
University of Hohenheim

Sleutelwoorden

Abstract

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.

Omschrijving

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.

Datums

Laatst geverifieerd: 10/31/2013
Eerste ingediend: 11/19/2013
Geschatte inschrijving ingediend: 11/26/2013
Eerst geplaatst: 12/04/2013
Laatste update ingediend: 11/26/2013
Laatste update geplaatst: 12/04/2013
Werkelijke startdatum van het onderzoek: 10/31/2011
Geschatte primaire voltooiingsdatum: 11/30/2012
Geschatte voltooiingsdatum van het onderzoek: 11/30/2012

Conditie of ziekte

Protein Malnutrition

Interventie / behandeling

Drug: Protein group

Drug: Control group

Fase

-

Armgroepen

ArmInterventie / behandeling
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: Protein group
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: Control group
Placebo product (Resource Maltodextrin, Nestlé Health Nutrition). Postoperative intake of 30 - 35 g powder per day over 6 months.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie 18 Years Naar 18 Years
Geslachten die in aanmerking komen voor studieAll
Accepteert gezonde vrijwilligersJa
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

Resultaat

Primaire uitkomstmaten

1. Excess weight loss [%] [At month 6]

Secundaire uitkomstmaten

1. Content of lean body mass in lost weight [%] [At month 6]

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.

Andere uitkomstmaten

1. Content of body fat in lost weight [%] [At month 6]

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.

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