Effect of Protein Supplementation After Bariatric Surgery

Status Completed

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02001636
Study type	Interventional
Source	University of Hohenheim
Contact
Status	Completed
Phase	N/A
Start date	November 2011
Completion date	December 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05502445` - The Nutritionist's Educational Intervention on the Protein Intake in Hospitalized Elderly People	N/A
Active, not recruiting	`NCT04565314` - ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth	N/A
Completed	`NCT03140696` - Formative Research Study to Address Protein Intake in Children and Analysis of Breast Milk Nutrient Content in Mothers	N/A
Completed	`NCT04791774` - Protein-bound Versus Free Amino Acid Nutrition During INtestinal Malabsorption in Critical Illness	N/A
Completed	`NCT01041456` - Laparoscopic Revision From Biliopancreatic Diversion to Gastric Bypass	N/A
Recruiting	`NCT06403137` - Plant Protein Blend and Milk Protein Supplements in Older Individuals	N/A
Completed	`NCT04587076` - Evaluation of Protein Intake and Micronutrient Supplementation After Bariatric Surgery
Not yet recruiting	`NCT06458387` - Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery	N/A
Completed	`NCT03181178` - Effect of a Complementary Food Supplement on Growth and Morbidity of Ghanaian Infants	N/A
Completed	`NCT01040533` - Laparoscopic Revision of Jejunoileal Bypass to Gastric Bypass	N/A
Not yet recruiting	`NCT05647135` - ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts
Recruiting	`NCT03947710` - Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness Indices	N/A
Completed	`NCT03032237` - Increase Protein Intake of Older Meal Service Clients With Readymade Protein-rich Meals and Foods	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Protein Supplementation After Bariatric Surgery — EPEAB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms