NCT02418975

Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition

Pre-operative Very Low-calorie Protein-based Versus Hypocaloric Enteral Nutrition to Improve Intra- and Post-operative Outcomes of Severely Obese Patients Undergoing Bariatric Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: San Giuseppe Moscati Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Pre-operative weight loss can reduce the risk intra- and post-operative complications but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.

Detailed description

Bariatric surgery is an important treatment strategy for obese patients having failed multiple diet-induced weight loss attempts. On the other hand, severly obese patients have also a high risk of both intra- and post-operative complications. Pre-operative weight loss can reduce these risks but no optimal pre-operative weight loss strategy has been investigated. Very-low-calorie diets (VLCDs) were proven to results in higher metabolic improvements in the short-term than balanced, hypocaloric diets. Therefore, the aim of the study is to investigate whether a VLCD results in lower intra-and post-operative complications compared to a hypocaloric diet. However, to achieve a optimal compliance in patients having experienced multiple dietary intervention failures, administration of the intervention will be performed by the enteral route using a naso-gastric feeding tube.

Conditions

• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
OTHER	Very low-calorie protein-based diet	Patients will receive a homemade very low-calorie (\~5 kcal/kg of ideal body weight /day) protein-based formula (milk proteins; 1.2 g per kilogram of ideal body weight) for 4 weeks by a polyurethane nasogastric feeding tube.
OTHER	Hypocaloric diet	Patients will receive a commercial balanced enteral formula (\~20 kcal/kg of ideal body weight /day; protein content, 1.0 g per kilogram of ideal body weight) for 4 weeks by a polyurethane nasogastric feeding tube.

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-04-17
• Last updated: 2017-03-21

Locations

1 site across 1 country: Italy