Coronary Artery DiseaseGENUTRINCT02202265
Polymorphisms in CD36 and STAT3 Genes and Different Dietary Interventions Among Patients With Coronary Artery Disease
A study testing Olive oil and Nuts in people with Coronary Artery Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
Background: Cardiovascular diseases are the major health problem worldwide and the understanding of genetic contributions on the development of cardiovascular diseases is increasing significantly. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Olive oil and Nuts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to 31 Dec 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with coronary arterial disease.
Who cannot join
- Psychiatric disease;
- Morbid obesity (BMI ≥ 40mg/m2);
- Expectancy of life less than 6 months;
- Pregnancy or lactation;
- Renal failure (in dialysis);
- Congestive heart failure;
Show all 11Show fewer
- Prior organ transplantation;
- Patients in wheelchair;
- Use of vitamin/nutritional supplements;
- Chronic use of non steroidal anti-inflammatory drugs;
- Participation in another experimental study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
Porto Alegre, Rio Grande do Sul, 90.620-001
About this study
Official title: Effect of Polymorphisms in CD36 and STAT3 Genes on Different Dietary Interventions Among Patients With Coronary Artery Disease: a Randomized Clinical Trial With a Nutrigenetic Approach
Background: Cardiovascular diseases are the major health problem worldwide and the understanding of genetic contributions on the development of cardiovascular diseases is increasing significantly. The CD36 is a protein associated with uptake of oxidized forms of LDL and the single nucleotide polymorphism (SNP) rs1761667 A/G in the CD36 gene is correlated with increased consumption of total fat. The transcription factor STAT3 is released during the inflammatory acute phase response and the SNP rs8069645 G/A in the STAT3 gene is associated with abdominal obesity and higher intake of saturated fat. Studies have been shown the benefits of the Mediterranean diet in secondary prevention of cardiovascular disease and these dietary patterns have been often studied with nutrigenetic approach; these studies, however, are often limited to European populations, making it difficult to generalize to different populations.
Hypothesis: Different dietary approaches may similarly influence in modifying metabolic, inflammatory and anthropometric profile, especially among patients with coronary arterial disease (CAD). The genetic interaction with environmental factors such as the nutrient intake, and the prescription of a different diet according to individual genotype, could influence the development and/or the treatment of cardiovascular diseases.
Objective: To evaluate the effect of three dietary approaches on metabolic, inflammatory and anthropometric profile in patients with CAD and possible interactions with polymorphisms in CD36 and STAT3 genes.
Read the detailed description
A randomized clinical trial with a nutrigenetic approach among patients ≥ 40 years diagnosed with CAD. Randomization will be made in blocks from a list of random numbers generated by site www.randomization.org (sealed opaque envelopes). A questionnaire with demographic and clinical data will be applied; systolic and diastolic blood pressure, waist, hip and neck circumferences, height and weight will be assessed. Nutrients intake will be assessed through a food diary. Laboratory evaluation will consist of lipid profile (LDL-cholesterol, HDL-cholesterol and total cholesterol, serum triglycerides), glycemic profile (fasting plasma glucose, glycated hemoglobin) and inflammatory profile (high-sensitivity C-reactive protein, fibrinogen, TNF-alpha, interleukin-6 and interleukin-10). Genotyping will be made by TaqMan SNP Genotyping Assay®. Patients will be randomized in three groups: Group 1 Intervention [Supplementation with nuts (SN)]: standard dietary guidelines + 30g of nuts a day; Group 2 Intervention [Supplementation with olive oil (SAO)]: standard dietary guidelines + 30ml of olive oil a day; Group 3 [Control diet (CO)]: standard dietary guidelines. Patients will be followed for three months (12 weeks) and the primary endpoint will be the change in LDL-cholesterol. The follow-up visits will be made at 30 days, 60 days and 90 days (final visit).
- Conditions
- Coronary Artery Disease
- Being tested
- Olive oil, Nuts, Control diet
- Keywords
- Heart Diseases
- Medical subject headings
- Coronary Artery Disease, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive oilDietary supplement
30ml a day of olive oil
NutsDietary supplement
30g a day of nuts
Control dietDietary supplement
Diet based on standard guidelines
| Study group | Role | What they receive |
|---|---|---|
| Control diet (standard dietary) | Active comparator | Patients will receive a control diet based on standard dietary guidelines Receives: Dietary Supplement: Control diet |
| Olive oil (30ml a day) | Experimental | Patients will receive a control diet based on standard dietary guidelines + 30ml of olive oil a day Receives: Dietary Supplement: Olive oil |
| Nuts (30g a day) | Experimental | Patients will receive a control diet based on standard dietary guidelines plus 30g of nuts a day Receives: Dietary Supplement: Nuts |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL
LDL-cholesterol, in mg/dL
Measured: twelve weeks
Secondary outcomes (22)
TC
total cholesterol (TC), in mg/dL)
Measured: twelve weeks
NHDL
non-HDL-cholesterol, in mg/dL
Measured: twelve weeks
HDL
HDL-cholesterol, in mg/dL
Measured: twelve weeks
TG
serum triglyceride, in mg/dL
Measured: twelve weeks
TyG index
Triglycerides/fasting glucose index, calculated according to (fasting triglycerides [mg/dL] x fasting glucose [mg/dL])/2
Measured: twelve weeks
HbA1C
glycated hemoglobin (HbA1C), in %
Measured: twelve weeks
FG
fasting glucose, in mg/dL
Measured: twelve weeks
Insulin
serum insulin, in UI/mL
Measured: twelve weeks
HOMA-IR
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), calculated according to fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5
Measured: twelve weeks
inflammatory profile
CRP-us, in mg/dL; IL-6, in mg/dL; IL-10, in mg/dL
Measured: twelve weeks
BW
body weight, in kg;
Measured: twelve weeks
BMI
body mass index (BMI), in kg/m2, calculated according to weight (kg)/height*height (m)
Measured: twelve weeks
WC
waist circumference, in cm
Measured: twelve weeks
NC
neck circumference, in cm
Measured: twelve weeks
LAP index
Lipid Accumulation Product Index (in cm.mmol.l), calculated for men: men (waist circumference [WC] - 65) x triglycerides (TG), and women (WC - 58) x TG
Measured: twelve weeks
DAAT index
Deep-Abdominal-Adipose-Tissue Index (in cm2), calculated for men (- 382.9 + [1.09 x weight] + [6.04 x waist circumference (WC)] + [- 2.29 x body mass index (BMI)]) and women (- 278 + [- 0.86 x weight] + [5.19 x WC])
Measured: twelve weeks
VAI index
Visceral Adiposity Index (log), calculated for men (waist circumference (WC)/[39 + (1.88 x body mass index (BMI)) x (triglycerides (TG)/1.03) x (1.31/HDL)]) and women (WC/[36.58 + (1.89 x BMI) x (TG/0.81) x (1.53/HDL)])
Measured: twelve weeks
PFA
plasma fatty acids, in percentage
Measured: twelve weeks
Mon
plasma monocytes, in percentage
Measured: twelve weeks
rs1761667 G>A
Polymorphism rs1761667 G>A in the CD36 gene
Measured: baseline
rs8069645 A>G
Polymorphism rs8069645 A>G in the STAT3 gene
Measured: baseline
Interaction diet * genotype
Interaction between dietary intervention, rs1761667 and rs8069645
Measured: twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startAug 2014
- Primary completion17 Jun 2016
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Responsible party
- Sponsor
- Investigators
- Aline Marcadenti, PhD, Principal investigator, Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)Vera L Portal, PhD, Study director, Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)Melissa M Markoski, PhD, Study director, Instituto de Cardiologia/Fundação Universitária de CardiologiaAlexandre S Quadros, PhD, Study director, Instituto de Cardiologia/Fundação Universitária de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202265
- Sponsor's protocol ID
- 48612013
- Acronym
- GENUTRI
- Status last verified
- Sep 2020
- First submitted
- 18 Jul 2014
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Dos Santos JL, Portal VL, Markoski MM, de Quadros AS, Bersch-Ferreira A, Marcadenti A. Effect of pecan nuts and extra-virgin olive oil on glycemic profile and nontraditional anthropometric indexes in patients with coronary artery disease: a randomized clinical trial. Eur J Clin Nutr. 2022 Jun;76(6):827-834. doi: 10.1038/s41430-021-01045-7. Epub 2021 Nov 22.
PubMed 34811509Campos VP, Portal VL, Markoski MM, Quadros AS, Bersch-Ferreira AC, Garavaglia J, Marcadenti A. Effects of a healthy diet enriched or not with pecan nuts or extra-virgin olive oil on the lipid profile of patients with stable coronary artery disease: a randomised clinical trial. J Hum Nutr Diet. 2020 Jun;33(3):439-450. doi: 10.1111/jhn.12727. Epub 2019 Dec 19.
PubMed 31856379Portal VL, Markoski MM, Quadros AS, Garofallo S, Santos JL, Oliveira A, Wechenfelder C, Campos VP, Souza PA, Machado L, Marcadenti A. Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial. Trials. 2016 Sep 5;17(1):437. doi: 10.1186/s13063-016-1564-1.
PubMed 27596284
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polymorphisms in CD36 and STAT3 Genes on Different Dietary Interventions Among Patients With Coronary Artery Disease: a Randomized Clinical Trial With a Nutrigenetic Approach
- ClinicalTrials.gov ID
- NCT02202265
- Acronym / sponsor ID
- GENUTRI / 48612013
- Conditions
- Coronary Artery Disease
- Keywords
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
- Study start
- Aug 2014
- Primary completion
- 17 Jun 2016 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 28 Jul 2014 (estimated)
- 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.
Background: Cardiovascular diseases are the major health problem worldwide and the understanding of genetic contributions on the development of cardiovascular diseases is increasing significantly. The CD36 is a protein associated with uptake of oxidized forms of LDL and the single nucleotide polymorphism (SNP) rs1761667 A/G in the CD36 gene is correlated with increased consumption of total fat. The transcription factor STAT3 is released during the inflammatory acute phase response and the SNP rs8069645 G/A in the STAT3 gene is associated with abdominal obesity and higher intake of saturated fat. Studies have been shown the benefits of the Mediterranean diet in secondary prevention of cardiovascular disease and these dietary patterns have been often studied with nutrigenetic approach; these studies, however, are often limited to European populations, making it difficult to generalize to different populations.
Hypothesis: Different dietary approaches may similarly influence in modifying metabolic, inflammatory and anthropometric profile, especially among patients with coronary arterial disease (CAD). The genetic interaction with environmental factors such as the nutrient intake, and the prescription of a different diet according to individual genotype, could influence the development and/or the treatment of cardiovascular diseases.
Objective: To evaluate the effect of three dietary approaches on metabolic, inflammatory and anthropometric profile in patients with CAD and possible interactions with polymorphisms in CD36 and STAT3 genes.
Detailed description
A randomized clinical trial with a nutrigenetic approach among patients ≥ 40 years diagnosed with CAD. Randomization will be made in blocks from a list of random numbers generated by site www.randomization.org (sealed opaque envelopes). A questionnaire with demographic and clinical data will be applied; systolic and diastolic blood pressure, waist, hip and neck circumferences, height and weight will be assessed. Nutrients intake will be assessed through a food diary. Laboratory evaluation will consist of lipid profile (LDL-cholesterol, HDL-cholesterol and total cholesterol, serum triglycerides), glycemic profile (fasting plasma glucose, glycated hemoglobin) and inflammatory profile (high-sensitivity C-reactive protein, fibrinogen, TNF-alpha, interleukin-6 and interleukin-10). Genotyping will be made by TaqMan SNP Genotyping Assay®. Patients will be randomized in three groups: Group 1 Intervention [Supplementation with nuts (SN)]: standard dietary guidelines + 30g of nuts a day; Group 2 Intervention [Supplementation with olive oil (SAO)]: standard dietary guidelines + 30ml of olive oil a day; Group 3 [Control diet (CO)]: standard dietary guidelines. Patients will be followed for three months (12 weeks) and the primary endpoint will be the change in LDL-cholesterol. The follow-up visits will be made at 30 days, 60 days and 90 days (final visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control diet (standard dietary) | Active comparator | Dietary Supplement: Control dietPatients will receive a control diet based on standard dietary guidelines |
| Olive oil (30ml a day) | Experimental | Dietary Supplement: Olive oilPatients will receive a control diet based on standard dietary guidelines + 30ml of olive oil a day |
| Nuts (30g a day) | Experimental | Dietary Supplement: NutsPatients will receive a control diet based on standard dietary guidelines plus 30g of nuts a day |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with coronary arterial disease.
Key exclusion criteria (11 listed)
- Psychiatric disease;
- Morbid obesity (BMI ≥ 40mg/m2);
- Expectancy of life less than 6 months;
- Pregnancy or lactation;
- Renal failure (in dialysis);
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 |
|---|---|---|
| Olive oil30ml a day of olive oil | Dietary supplement | Olive oil (30ml a day) |
| Nuts30g a day of nuts | Dietary supplement | Nuts (30g a day) |
| Control dietDiet based on standard guidelines | Dietary supplement | Control diet (standard dietary) |
Primary outcome
LDL
Time frame: twelve weeks
LDL-cholesterol, in mg/dL
22 secondary outcomes
TC
Time frame: twelve weeks
NHDL
Time frame: twelve weeks
HDL
Time frame: twelve weeks
TG
Time frame: twelve weeks
TyG index
Time frame: twelve weeks
HbA1C
Time frame: twelve weeks
FG
Time frame: twelve weeks
Insulin
Time frame: twelve weeks
HOMA-IR
Time frame: twelve weeks
inflammatory profile
Time frame: twelve weeks
BW
Time frame: twelve weeks
BMI
Time frame: twelve weeks
WC
Time frame: twelve weeks
NC
Time frame: twelve weeks
LAP index
Time frame: twelve weeks
DAAT index
Time frame: twelve weeks
VAI index
Time frame: twelve weeks
PFA
Time frame: twelve weeks
Mon
Time frame: twelve weeks
rs1761667 G>A
Time frame: baseline
rs8069645 A>G
Time frame: baseline
Interaction diet * genotype
Time frame: twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Derived from this study: PubMed 34811509Dos Santos JL, Portal VL, Markoski MM, de Quadros AS, Bersch-Ferreira A, Marcadenti A. Effect of pecan nuts and extra-virgin olive oil on glycemic profile and nontraditional anthropometric indexes in patients with coronary artery disease: a randomized clinical trial. Eur J Clin Nutr. 2022 Jun;76(6):827-834. doi: 10.1038/s41430-021-01045-7. Epub 2021 Nov 22.
- Derived from this study: PubMed 31856379Campos VP, Portal VL, Markoski MM, Quadros AS, Bersch-Ferreira AC, Garavaglia J, Marcadenti A. Effects of a healthy diet enriched or not with pecan nuts or extra-virgin olive oil on the lipid profile of patients with stable coronary artery disease: a randomised clinical trial. J Hum Nutr Diet. 2020 Jun;33(3):439-450. doi: 10.1111/jhn.12727. Epub 2019 Dec 19.
- Derived from this study: PubMed 27596284Portal VL, Markoski MM, Quadros AS, Garofallo S, Santos JL, Oliveira A, Wechenfelder C, Campos VP, Souza PA, Machado L, Marcadenti A. Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial. Trials. 2016 Sep 5;17(1):437. doi: 10.1186/s13063-016-1564-1.
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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.
Aline Marcadenti, PhD principal investigator
Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
Vera L Portal, PhD study director
Instituto de Cardiologia/Fundação Universitária de Cardiologia (IC/FUC)
Melissa M Markoski, PhD study director
Instituto de Cardiologia/Fundação Universitária de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive oil and Nuts in people with Coronary Artery Disease, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 10 Sep 2020. 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 Brazil. 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?
Results are not available in the source record.
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?
LDL (time frame: twelve weeks). 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 NCT02202265, which also lists 3 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 10 Sep 2020.