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

Universidad de Concepcion

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Dietary Supplement: Low-fat diet; Dietary Supplement: High-fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07087704

CEC-SSC: 21-09-48 (Other Identifier)

CEBB 530-2019-M

ANID FONDECYT INICIACION (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Low-fat diet

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Low-fat diet

High-fat Chilean diet supplemented with Gevuina avellana

Experimental group

Description:

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

Treatment:

Dietary Supplement: High-fat diet