Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-28 @ 6:03 AM
Study NCT ID:
NCT07087704
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2025-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Chilean Diet Supplemented With Gevuina Avellana on Lipid Profile in Humans With Hypercholesterolemia
Sponsor:
Universidad de Concepcion
Organization:
Study Overview
Official Title:
Effects of a Chilean Diet Supplemented With Gevuina Avellana on Lipid Profile in Humans With Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRODICHI
Brief Summary:
The purpose of this study is to determine if supplementing a Chilean diet with Chilean hazelnut (Gevuina avellana) improves cholesterol levels in adults with hypercholesterolemia. The main question is whether this supplementation reduces total serum cholesterol compared to a low-fat diet without hazelnut.
Detailed Description:
This is a 6-month randomized controlled parallel study involving hypercholesterolemic volunteers (serum cholesterol \> 200 mg/dL, with or without triglycerides \> 150 mg/dL) aged 18-60 years from Concepción, Chile. Participants are randomly assigned to two groups:
Intervention group: Receives the Chilean diet supplemented daily with 30 g of Chilean hazelnut (Gevuina avellana).
Control group: Receives dietary advice to follow a low-fat diet based on American Heart Association recommendations, without hazelnut supplementation.
Primary outcome is total serum cholesterol. Secondary assessments include anthropometric measures, blood pressure, diet adherence, physical activity, sociodemographic variables, smoking habits, medical diagnoses, medication use, and biochemical markers of lipid profile, oxidative damage, antioxidant capacity, endothelial peptides, and inflammation.
Data collection occurs at baseline, 2, 4, and 6 months. Individual motivational interviews and group motivational sessions (approximately 25 participants each) are conducted to enhance adherence. Blood samples for lipid profiling and other biochemical analyses are collected fasting at baseline and study completion.
Blood fractionation is performed to obtain plasma, serum, erythrocytes, and peripheral blood mononuclear cells (PBMCs) for detailed fatty acid profiling and biomarker measurements.
This study aims to provide insight into the potential cardiovascular benefits of Gevuina avellana supplementation in a Chilean dietary context.
Intervention group: Receives the Chilean diet supplemented daily with 30 g of Chilean hazelnut (Gevuina avellana).
Control group: Receives dietary advice to follow a low-fat diet based on American Heart Association recommendations, without hazelnut supplementation.
Primary outcome is total serum cholesterol. Secondary assessments include anthropometric measures, blood pressure, diet adherence, physical activity, sociodemographic variables, smoking habits, medical diagnoses, medication use, and biochemical markers of lipid profile, oxidative damage, antioxidant capacity, endothelial peptides, and inflammation.
Data collection occurs at baseline, 2, 4, and 6 months. Individual motivational interviews and group motivational sessions (approximately 25 participants each) are conducted to enhance adherence. Blood samples for lipid profiling and other biochemical analyses are collected fasting at baseline and study completion.
Blood fractionation is performed to obtain plasma, serum, erythrocytes, and peripheral blood mononuclear cells (PBMCs) for detailed fatty acid profiling and biomarker measurements.
This study aims to provide insight into the potential cardiovascular benefits of Gevuina avellana supplementation in a Chilean dietary context.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: