Effect of phytosterol capsule supplementation associated with the National Cholesterol Education Program Step 2 diet on low-density lipoprotein in children and adolescents with dyslipidemia: A double-blind crossover trial.
Study Goal
To evaluate the effect of phytosterol capsule supplementation combined with the NCEP Step 2 diet on LDL-C levels in children and adolescents with dyslipidemia.
Results Summary
Phytosterol supplementation did not significantly reduce LDL-C, TC, HDL-C, insulin, triglycerides, or blood pressure compared to the control group. High capsule adherence but low diet adherence may have influenced the results.
Population
Children and adolescents (n=31, mean age 9.0 ± 2.22 years, BMI z-score 1.65 ± 1.47 kg/m²) with dyslipidemia.
Effective Dosage
Not specified
Duration
Not specified
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet | no change | LDL-cholesterol concentrations | children and adolescents with dyslipidemia | - | did not reduce | #1 |
phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet | no change | rate of change for LDL-C | children and adolescents with dyslipidemia | - | was not different | #2 |
phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet | no change | TC | children and adolescents with dyslipidemia | - | No significant reduction was observed | #3 |
phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet | no change | HDL-C | children and adolescents with dyslipidemia | - | No significant reduction was observed | #4 |
phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet | no change | insulin | children and adolescents with dyslipidemia | - | No significant reduction was observed | #5 |
phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet | no change | triglycerides | children and adolescents with dyslipidemia | - | No significant reduction was observed | #6 |
phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet | no change | systolic blood pressure | children and adolescents with dyslipidemia | - | No significant reduction was observed | #7 |
phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet | no change | diastolic blood pressure | children and adolescents with dyslipidemia | - | No significant reduction was observed | #8 |
OBJECTIVE: To evaluate the effect of phytosterol capsule supplementation associated with the National Cholesterol Education Program (NCEP) Step 2 diet on LDL-C levels in children and adolescents with dyslipidemia. METHODS: This is a randomized, double-blind, crossover trial conducted with children and adolescents (n = 31; mean ± SD, age 9.0 ± 2.22 years, BMI zscore 1.65 ± 1.47 kg/m RESULTS: The rate of change for LDL-C was not different between intervention and control groups (p=0.30). No significant reduction was also observed for TC (p=0.47), HDL-C (p=0.97), insulin (p=0.27), triglycerides (p=0.38), systolic blood pressure (p=0.11), and diastolic blood pressure (p=0.57) compared to control group. Although we observed a high adherence to the capsule intake (95.7% in phytosterol and 93.8% in the control group), the low adherence to the diet may have contributed to explaining the results. CONCLUSION: Daily phytosterol capsules supplementation associated with the NCEP Step 2 diet did not reduce LDL-cholesterol concentrations in children and adolescents with dyslipidemia.