Protective role of dietary intervention rich in unsaturated fats in dyslipidemic childre

Completed

• Conditions: Familiar dyslipidemia; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN12261900
• Lead Sponsor: Regione Piemonte

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28606702 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29753234

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-10
• Study Completion: 2016-12-31
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Changes in serum lipid profile triglycerides, total cholesterol, high density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol<br>2. Changes in erythrocyte phospholipids composition<br>3. Changes in anthropometric characteristics (age, weight, height, body mass index)<br>4. Changes in blood pressure (diastolic and systolic blood pressure)<br>5. Changes in oxidized LDL and paraoxonase 1 (PON-1)<br>6. Changes in markers of inflammation<br>7. Changes in microbiota composition<br>All assessed at baseline and at the end of intervention (8 weeks)