Glycemic Index Variation During Low-carbohydrate Enteral Formula With and Without Fructose in Critically Ill Patients: A Cross-over Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Hospital Moinhos de Vento
- Enrollment
- 25
- Primary Endpoint
- Glycemic Variability
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Diet 1
Low-carbohydrate Enteral Formula With Fructose
Intervention: Enteral Formula With Fructose (Dietary Supplement)
Diet 2
Low-carbohydrate Enteral Formula Without Fructose
Intervention: Enteral Formula Without Fructose (Dietary Supplement)
Outcomes
Primary Outcomes
Glycemic Variability
Time Frame: four days
To evaluate the glycemic oscillation during the use of enteral feedings
Secondary Outcomes
No secondary outcomes reported
Investigators
Magali Kumbier
Nutritionist
Hospital Moinhos de Vento