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

San Giuseppe Moscati Hospital

Status: Unknown

Conditions: Perioperative/Postoperative Complications

Treatments: Other: Hypocaloric diet; Other: Very low-calorie protein-based diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02418975

CECN/132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient candidate to laparoscopic bariatric surgery (gastric bypass or sleeve gastrectomy) after multi-disciplinary pre-operative evaluation
• Availability to long-term post-operative follow-up
• Normal kidney function serum creatinine ≤ 1,2 mg/dL and glomerular filtration rate ≥ 90 mL/min
• Normal liver function (aspartate amino-transferase and/or alanine amino-transferase and/or gamma glutamyl transferase < 2 x N)
• written informed consent

Exclusion criteria

• age <18 or >60 anni
• serum creatinine >1,2 mg/dl
• liver failure (Child-Pugh ≥ A)
• insuline-dependent diabetes mellitus
• atrioventricular block with QT > 0,44 ms
• Cardiac arrythmias
• Moderate-severe cardiac failure
• Hypokaliemia
• Chronic diarrhoea or vomitus
• 12-month previous cardio-vascular disease
• pregnancy and/or lactation
• current/previous neoplastic disease
• psychiatric disorders
• know gastro-intestinal diseases
• other controindications to enteral nutrition
• moderate-severe hypo-albuminemia (<3.0 mg/dL)
• 6-month previous diet-induced weight loss
• intragastric balloon
• unavailability to planned measurements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Very low-calorie protein-based diet

Experimental group

Description:

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.

Treatment:

Other: Very low-calorie protein-based diet

Hypocaloric diet

Active Comparator group

Description:

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.

Treatment:

Other: Hypocaloric diet