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| ID | Type | Description | Link |
|---|---|---|---|
| CEC-SSC: 21-09-48 | Other Identifier | Comité Ético Científico del Servicio de Salud Concepción | |
| ANID FONDECYT INICIACION | Other Identifier | 1119064 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol (mg/dL) | Total serum cholesterol under fasting condition | From enrollment to the end of treatment at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure (mmHg) | Blood pressure measured by a semi-automatic sphygmomanometer | From enrollment to the end of treatment at 6 months |
| Body weight (kg) | Body weight is measured using a portable digital scale (Seca®) with a precision of 100 g, placed on a flat, horizontal, and firm surface. Participants are asked to remove their shoes and wear minimal clothing to ensure accurate measurement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miquel Martorell, PhD | Centro de Vida Saludable | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratorio Prevegen | Concepción | Biobio | 4070386 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41791910 | Derived | Ramos-Pardo S, Ramirez-Alarcon K, Gonzalez-Contreras C, Valdebenito E, Sureda A, Martorell M. Effect of a Chilean diet supplemented with Gevuina avellana molina versus a low-fat diet on cardiometabolic, oxidative stress, and inflammatory biomarkers in Chilean adults with hypercholesterolemia: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2026 Jun;36(6):104608. doi: 10.1016/j.numecd.2026.104608. Epub 2026 Feb 4. |
| Label | URL |
|---|---|
| Research Thesis on Plasma Biochemical Markers | View source |
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Only IPD used in the results publication
Once the results are published
Contact to Miquel Martorell at mmartorell@udec.cl Explain the data required and the purpose of use
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D059305 | Diet, High-Fat |
| D018752 | Diet, Fat-Restricted |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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. |
|
|
| From enrollment to the end of treatment at 6 months |
| Height (m) | Height is measured using a portable stadiometer (Seca® 213) with 0.1 cm precision. Participants stand barefoot with heels together (forming a 45-60° angle), back straight and in contact with the stadiometer, fully extended. The head is positioned in the Frankfurt horizontal plane. Participants are instructed to take a deep breath and remain still. The headpiece is gently lowered to contact the head, applying slight pressure to compress the hair. | From enrollment to the end of treatment at 6 months |
| Body Mass Index (kg/m2) | Weight and height will be combined to report BMI in kg/m2) | From enrollment to the end of treatment at 6 months |
| Waist circumference (mm) | Waist circumference is measured using a non-stretchable measuring tape (Seca® 201) with 0.1 cm precision. The participant stands upright, shirtless or with the waist area exposed, feet 25-30 cm apart, arms relaxed at the sides, and weight evenly distributed. Measurement is taken at the midpoint between the lower rib and the iliac crest along the midaxillary line. Reference points are palpated and marked. The tape is placed horizontally, snug but not compressing soft tissues, and measurement is taken at the end of a normal exhalation. Two measurements are taken; if they differ by more than 1 cm, a third is taken. The final value is the average of the two closest readings. | From enrollment to the end of treatment at 6 months |
| LDL cholesterol (mg/dL) | LDL cholesterol under fasting condition | From enrollment to the end of treatment at 6 months |
| HDL cholesterol (mg/dL) | HDL cholesterol under fasting condition | From enrollment to the end of treatment at 6 months |
| Triglycerides (mg/dL) | Triglycerides under fasting condition | From enrollment to the end of treatment at 6 months |
| Superoxide dismutase activity | Superoxide dismutase activity is measured in plasma and erythrocytes using spectrophotometric methods. | From enrollment to the end of treatment at 6 months |
| Catalase activity | Catalase is measured in plasma and erythrocytes using spectrophotometric methods. | From enrollment to the end of treatment at 6 months |
| Homocysteine | Plasma homocysteine is measured using a commercial ELISA kit, following the manufacturer's instructions. | From enrollment to the end of treatment at 6 months |
| Adiponectin | Adiponectin levels in plasma are measured using a commercial ELISA kit according to the manufacturer's protocol | From enrollment to the end of treatment at 6 months |
| Oxidized low-density lipoprotein (LDLox) | Oxidized low-density lipoprotein (LDLox) levels in plasma are measured using a commercial ELISA kit following the manufacturer's instructions. | From enrollment to the end of treatment at 6 months |
| Research Thesis on PBMCs Biochemical Markers | View source |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |