Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients

Hospital Moinhos de Vento

Status and phase: Completed; Phase 4

Conditions: Critical Illness

Treatments: Dietary Supplement: Enteral Formula With Fructose; Dietary Supplement: Enteral Formula Without Fructose

Study type: Interventional

Funder types: Other

Identifiers

NCT03003507

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Details and patient eligibility

About

Hyperglycemia is a known risk factor for mortality in critically ill patients. Most of these patients receive enteral feeding. There is controversy about ideal carbohydrate composition of these diets. The aim of this study was to compare an enteral formula with the same proportion of carbohydrates with and without fructose on blood glucose levels.

Full description

Randomized, cross-over, controlled, double-blind clinical trial without washout. Adult patients admitted to the ICU who presented capillary glycemia values> 180mg / dl with a full and exclusive enteral diet. They were randomized and observed for 4 days (2 days with each diet: with / without fructose). Capillary glycemia was measured 4 / 4h.

Enrollment: 25 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Critical Illness
• Exclusive enteral diet
• Enteral diet with full nutritional value
• Hyperglycemia ≥180 mg / dl

Exclusion criteria

• Oral feeding
• NPT (Total or Partial Parenteral Nutrition)
• Patient without indication of use of study diets

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups

Diet 1

Active Comparator group

Description:

Low-carbohydrate Enteral Formula With Fructose

Treatment:

Dietary Supplement: Enteral Formula With Fructose

Diet 2

Active Comparator group

Description:

Low-carbohydrate Enteral Formula Without Fructose

Treatment:

Dietary Supplement: Enteral Formula Without Fructose