Familiar dyslipidemia Nutritional, Metabolic, Endocrine
Conditions
Interventions
The study is an 8-week randomized, controlled, parallel, single-blind dietary intervention study. Subjects receive dietary guidelines and individually randomized to the following three parallel group
Sponsors
Regione Piemonte
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 5-17 years affected by primary dyslipidemia (familiar hypercholesterolemia, familiar combined hyperlipidemia and undefined hypercholesterolemia), 2. Total cholesterol and/or triglycerides value higher than their age- and sex-specific 90th percentile 3. Body mass index (BMI) <95th percentile
Exclusion criteria
Exclusion criteria: 1. Secondary dyslipidemias, overweight or obesity (BMI = 85th and = 95th percentile, age and sex matched, respectively) 2. Children under lipid-lowering treatment (including functional foods) from the 3 months before the beginning of the study 3. History of renal, endocrine, liver disorders, or chronic diseases (i.e., immunologic, neurologic, or oncohematologic disorders) 4. Smokers 5. Use of any drugs, supplements, specific prebiotics or probiotics or medications at least one month before the beginning of the experiment. 6. Subjects with specific aversion or allergies to food under study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endogenous oxidized DNA bases (using enzyme formamidopyrimidine-DNA glycosylase) measured by Comet assay in peripheral blood mononuclear cells at baseline (t=0) and at the end of intervention (t=8 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in serum lipid profile triglycerides, total cholesterol, high density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol 2. Changes in erythrocyte phospholipids composition 3. Changes in anthropometric characteristics (age, weight, height, body mass index) 4. Changes in blood pressure (diastolic and systolic blood pressure) 5. Changes in oxidized LDL and paraoxonase 1 (PON-1) 6. Changes in markers of inflammation 7. Changes in microbiota composition All assessed at baseline and at the end of intervention (8 weeks) | — |
Countries
Italy
Outcome results
None listed