HypercholesterolemiaPRODICHINCT07087704
Effects of a Chilean Diet Supplemented With Gevuina Avellana on Lipid Profile in Humans With Hypercholesterolemia
A study testing High-fat diet and Low-fat diet in people with Hypercholesterolemia, run by Universidad de Concepcion at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- High-fat diet and Low-fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChile
- Study dates
- 8 Mar 2022to 13 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- High-fat diet, Low-fat diet
- Keywords
- lipid profile, chilean diet, Gevuina avellana, Cardiovascular disease prevention, nutritional intervention, chilean hazelnut
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat dietDietary supplement
Also called Chilean hazelnut supplementation, Gevuina avellana supplementation
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.
Low-fat dietDietary supplement
Also called MINSAL guidelines for dyslipidemia management, Chilean Ministry of Health technical guidelines for dyslipidemia management
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: High-fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol (mg/dL)
Total serum cholesterol under fasting condition
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (13)
Blood pressure (mmHg)
Blood pressure measured by a semi-automatic sphygmomanometer
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: From enrollment to the end of treatment at 6 months
LDL cholesterol (mg/dL)
LDL cholesterol under fasting condition
Measured: From enrollment to the end of treatment at 6 months
HDL cholesterol (mg/dL)
HDL cholesterol under fasting condition
Measured: From enrollment to the end of treatment at 6 months
Triglycerides (mg/dL)
Triglycerides under fasting condition
Measured: 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.
Measured: From enrollment to the end of treatment at 6 months
Catalase activity
Catalase is measured in plasma and erythrocytes using spectrophotometric methods.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start8 Mar 2022
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Concepcion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miquel Martorell, PhD, Principal investigator, Centro de Vida Saludable
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087704
- Sponsor's protocol ID
- CEBB 530-2019-M
- Other IDs
- CEC-SSC: 21-09-48, ANID FONDECYT INICIACION
- Acronym
- PRODICHI
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Publications
Gonzalez-Contreras C, Ramos-Pardo S, Valdebenito EA, Ramirez-Alarcon K, Zuniga FA, Quetglas-Llabres MM, Sureda A, Martorell M. Effects of a Chilean Hazelnut-Supplemented Diet on Oxidative Stress and Cytokine Expression in PBMCs of Hypercholesterolemic Adults: A Randomized Controlled Trial. Nutrients. 2026 Oct 16;18(20):3400. doi: 10.3390/nu18203400.
PubMed 42942971Ramos-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.
PubMed 41791910
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Chilean Diet Supplemented With Gevuina Avellana on Lipid Profile in Humans With Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT07087704
- Acronym / sponsor ID
- PRODICHI / CEBB 530-2019-M
- Conditions
- Hypercholesterolemia
- Keywords
- lipid profile, chilean diet, Gevuina avellana, Cardiovascular disease prevention, nutritional intervention, chilean hazelnut
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Universidad de ConcepcionUniversity, hospital or other
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fat diet | Active comparator | Dietary Supplement: Low-fat dietThe 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 |
| High-fat Chilean diet supplemented with Gevuina avellana | Experimental | Dietary Supplement: High-fat dietThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat dietAlso: Chilean hazelnut supplementation, Gevuina avellana supplementationThe 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. | Dietary supplement | High-fat Chilean diet supplemented with Gevuina avellana |
| Low-fat dietAlso: MINSAL guidelines for dyslipidemia management, Chilean Ministry of Health technical guidelines for dyslipidemia managementThe 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. | Dietary supplement | Low-fat diet |
Primary outcome
Total cholesterol (mg/dL)
Time frame: From enrollment to the end of treatment at 6 months
Total serum cholesterol under fasting condition
13 secondary outcomes
Blood pressure (mmHg)
Time frame: From enrollment to the end of treatment at 6 months
Body weight (kg)
Time frame: From enrollment to the end of treatment at 6 months
Height (m)
Time frame: From enrollment to the end of treatment at 6 months
Body Mass Index (kg/m2)
Time frame: From enrollment to the end of treatment at 6 months
Waist circumference (mm)
Time frame: From enrollment to the end of treatment at 6 months
LDL cholesterol (mg/dL)
Time frame: From enrollment to the end of treatment at 6 months
HDL cholesterol (mg/dL)
Time frame: From enrollment to the end of treatment at 6 months
Triglycerides (mg/dL)
Time frame: From enrollment to the end of treatment at 6 months
Superoxide dismutase activity
Time frame: From enrollment to the end of treatment at 6 months
Catalase activity
Time frame: From enrollment to the end of treatment at 6 months
Homocysteine
Time frame: From enrollment to the end of treatment at 6 months
Adiponectin
Time frame: From enrollment to the end of treatment at 6 months
Oxidized low-density lipoprotein (LDLox)
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Derived from this study: PubMed 42942971Gonzalez-Contreras C, Ramos-Pardo S, Valdebenito EA, Ramirez-Alarcon K, Zuniga FA, Quetglas-Llabres MM, Sureda A, Martorell M. Effects of a Chilean Hazelnut-Supplemented Diet on Oxidative Stress and Cytokine Expression in PBMCs of Hypercholesterolemic Adults: A Randomized Controlled Trial. Nutrients. 2026 Oct 16;18(20):3400. doi: 10.3390/nu18203400.
- Derived from this study: PubMed 41791910Ramos-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.
- Research Thesis on Plasma Biochemical MarkersLink provided by the sponsor.
- Research Thesis on PBMCs Biochemical MarkersLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
Related trials for Hypercholesterolemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miquel Martorell, PhD principal investigator
Centro de Vida Saludable
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat diet and Low-fat diet in people with Hypercholesterolemia, run by Universidad de Concepcion at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (mg/dL) (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07087704, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.