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

NCT07087704 | Completed

• 3 other identifiers: CEBB 530-2019-MCEC-SSC: 21-09-48ANID FONDECYT INICIACION
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

lipid profile; chilean diet; Gevuina avellana; Cardiovascular disease prevention; nutritional intervention; chilean hazelnut

Outcome Measures

Primary Outcomes (1)

• Total cholesterol (mg/dL)

  Total serum cholesterol under fasting condition

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (13)

• Blood pressure (mmHg)

  From enrollment to the end of treatment at 6 months

• Body weight (kg)

  From enrollment to the end of treatment at 6 months

• Height (m)

  From enrollment to the end of treatment at 6 months

• Body Mass Index (kg/m2)

  From enrollment to the end of treatment at 6 months

• Waist circumference (mm)

  From enrollment to the end of treatment at 6 months

Study Arms (2)

Low-fat diet

ACTIVE COMPARATOR

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

Dietary Supplement: Low-fat diet

High-fat Chilean diet supplemented with Gevuina avellana

EXPERIMENTAL

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

Dietary Supplement: High-fat diet

Interventions

High-fat diet 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.

Also known as: Chilean hazelnut supplementation, Gevuina avellana supplementation

High-fat Chilean diet supplemented with Gevuina avellana

Low-fat diet 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.

Also known as: MINSAL guidelines for dyslipidemia management, Chilean Ministry of Health technical guidelines for dyslipidemia management

Low-fat diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Concepcion: lead

Study Sites (1)

Laboratorio Prevegen

Concepción, Región del Biobío, 4070386, Chile

Location

Related Links

• Research Thesis on Plasma Biochemical Markers
• Research Thesis on PBMCs Biochemical Markers

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Diet, High-Fat; Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Diet Therapy; Nutrition Therapy; Therapeutics

Study Officials

• Miquel Martorell, PhD

  Centro de Vida Saludable

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 28, 2025
• Study Start: March 8, 2022
• Primary Completion: September 13, 2022
• Study Completion: September 13, 2022
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Once the results are published
• Access Criteria: Contact to Miquel Martorell at mmartorell@udec.cl Explain the data required and the purpose of use

Locations

CL (1)