Effects of a Chilean Diet Supplemented With Gevuina Avellana on Lipid Profile in Humans With Hypercholesterolemia

NCT ID: NCT07087704

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-08
• Study Completion Date: 2022-09-13

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.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low-fat diet

The control group maintained a low-fat diet (\<30% total energy value) based on the Ministerio de Salud de Chile (MINSAL) technical guidelines for dyslipidemia management

Group Type: ACTIVE_COMPARATOR

Low-fat diet

Intervention Type: DIETARY_SUPPLEMENT

The group maintains a low-fat diet (\<30% of total energy value) based on the Chilean Ministry of Health (MINSAL) technical guidelines for dyslipidemia management. To promote adherence to the diet, individual motivational interviews and group sessions (with approximately 25 participants) are conducted once per month.

High-fat Chilean diet supplemented with Gevuina avellana

The experimental group followed a Chilean diet (adapted from the Mediterranean Diet using Chilean ingredients) supplemented with 30 g/day of Gevuina avellana and a diet of 40% total energy value

Group Type: EXPERIMENTAL

High-fat diet

Intervention Type: DIETARY_SUPPLEMENT

The group follows a Chilean diet (adapted from the Mediterranean Diet using Chilean ingredients) supplemented with 30 g/day of Gevuina avellana and providing 40% of total energy value from fat. To promote adherence to the diet, individual motivational interviews and group sessions (with approximately 25 participants) are conducted once per month. Each participant is provided once a month with individually packaged Chilean hazelnuts to reach a daily intake of 30 g.

Interventions

High-fat diet

The group follows a Chilean diet (adapted from the Mediterranean Diet using Chilean ingredients) supplemented with 30 g/day of Gevuina avellana and providing 40% of total energy value from fat. To promote adherence to the diet, individual motivational interviews and group sessions (with approximately 25 participants) are conducted once per month. Each participant is provided once a month with individually packaged Chilean hazelnuts to reach a daily intake of 30 g.

Intervention Type: DIETARY_SUPPLEMENT

Low-fat diet

The group maintains a low-fat diet (\<30% of total energy value) based on the Chilean Ministry of Health (MINSAL) technical guidelines for dyslipidemia management. To promote adherence to the diet, individual motivational interviews and group sessions (with approximately 25 participants) are conducted once per month.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Chilean hazelnut supplementation; Gevuina avellana supplementation; MINSAL guidelines for dyslipidemia management; Chilean Ministry of Health technical guidelines for dyslipidemia management

Eligibility Criteria

Inclusion Criteria

• Serum cholesterol level greater than 200 mg/dL with or without triacylglycerol greater than 150 mg/dL
• Have received both doses included in the SARS-CoV-2 vaccination campaign and possess their corresponding mobility pass.

Exclusion Criteria

• Be undergoing medical treatment for hypercholesterolemia.
• Have systemic diseases such as diabetes, hypertension, kidney, or liver disease.
• Pregnant or breastfeeding women.
• Have a household member or close relative who has been previously recruited.
• Have allergies to tree nuts.
• Have an electronic implant such as a pacemaker.
• Also, individuals who do not meet the minimum conditions compatible with the study modality will not be able to participate in the intervention, such as: having access to an electronic device such as a cellphone or computer; having access to mobile internet or Wi-Fi at home; or having the necessary knowledge or support to use the platform

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Concepcion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miquel Martorell, PhD

Role: PRINCIPAL_INVESTIGATOR

Centro de Vida Saludable

Locations

Laboratorio Prevegen

Concepción, Región del Biobío, Chile

Countries

Chile

Related Links

https://vidasaludable.udec.cl/node/918

Research Thesis on Plasma Biochemical Markers

https://vidasaludable.udec.cl/node/573

Research Thesis on PBMCs Biochemical Markers

Other Identifiers

CEC-SSC: 21-09-48

Identifier Type: OTHER

Identifier Source: secondary_id

ANID FONDECYT INICIACION

Identifier Type: OTHER

Identifier Source: secondary_id

CEBB 530-2019-M

Identifier Type: -

Identifier Source: org_study_id