CFDB - Cystic Fibrosis DataBase

primary studies published RCT

Randomized trial of efficacy and safety of dornase alfa delivered by eRapid nebulizer in cystic fibrosis patients

Study design (if review, criteria of inclusion for studies)

Randomized clinical trial

Participants

44 children and adolescents with cystic fibrosis

Interventions

Patients were randomized to receive for three months either a high fat, high-calorie diet (n = 22) or a low glycemic index/high fat, high-calorie diet (n = 22) with similar calorie and macronutrients composition.

Outcome measures

Serum levels of lipid profiles (triglyceride, total cholesterol, HDL cholesterol, LDL cholesterol), insulin, fasting blood glucose, and glycated hemoglobin were measured at baseline and after the intervention.

Main results

Between-group differences were significant only for fasting blood glucose (P < 0.001). However, fasting blood glucose (P = 0.003) and glycated hemoglobin (P = 0.002) significantly decreased after the intervention in the low glycemic index group, while in another group a significant increase in fasting blood glucose (P = 0.038) and triglyceride (P = 0.004) was found. No significant within-group differences were observed in other variables in both groups.

Authors' conclusions

It seems that adherence to a low glycemic index/high fat, high-calorie diet can improve glycemic indices in children and adolescents with cystic fibrosis compared to the high fat, high-calorie diet.

Keywords: Low glycemic index meal; Food; non pharmacological intervention - diet; Diabetes Mellitus; Pancreatic Diseases; Gastrointestinal Diseases;