Cardiovascular DiseasesNCT02732223
Combined Bioactive Therapy Effects Over Cardiovascular Markers in Statin Treated Patients
A study testing Functional treatment in people with Cardiovascular Diseases, run by Instituto Dante Pazzanese de Cardiologia.
Trial summary
Atherosclerosis, one major cause of morbidity and mortality worldwide, is a complex and multifactorial disease triggered especially due to high level of plasma lipids and that involves three mainly conditions: chronic inflammation, dyslipidemia and oxidative stress. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Functional treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The primary selection criteria were current statin (simvastatin or atorvastatin) and hypoglycemic treatment (metformin and/or gliclazide).
Who cannot join
- Exclusion criteria were patients who were taking omega 3 fatty acids, plant sterol or green tea supplements; uncontrolled diabetes (HbA1c > 7.5%) or dyslipidemia (LDL-C > 100 mg/dL); pregnant females; and patients who presented any congenital cardiac disorders, uncontrolled endocrine, renal or hepatic disease and excessive alcohol consumption.
About this study
Official title: Complementary Therapy of Omega 3 Fatty Acids, Plant Sterols and Polyphenols Over Cardiovascular Markers in Statin Treated Patients
Atherosclerosis, one major cause of morbidity and mortality worldwide, is a complex and multifactorial disease triggered especially due to high level of plasma lipids and that involves three mainly conditions: chronic inflammation, dyslipidemia and oxidative stress. Taking into account the high costs of disease management, eminent suboptimal response and low compliance to drug therapies, the combined use of natural bioactive compound able to reduce atherosclerosis risk could provide an additional protection. In this study, the effects of three bioactive components, namely omega-3 fatty acids, plants sterols and polyphenols present in green tea, will be evaluated over atherosclerosis biomarkers in individuals with dyslipidemia controlled by drugs. It will be carried out a randomized, double-blind, placebo-controlled, crossover clinical study, with participation of 70 subjects. At each intervention period, study participants will receive a packaged for the functional or placebo treatment. Functional treatment packaged will be composed by omega 3 softgels (fish oil), a chocolate containing plant sterols and green tea. Placebo treatment will be composed by corn oil softgels, regular chocolate, and anise tea. Subjects will be advised to consume the softgels and chocolate twice a day after main meals and to drink two cups of tea per day. After evaluation of inflammation, dyslipidemia and oxidative stress biomarkers, subjects with the greatest response to the functional treatment will be selected for additional 6 weeks of functional intervention associated to a reduction of the hypolipidaemic drugs intake, which will be prescribed individually after evaluation of the responsible physician.
Read the detailed description
From eligible subjects, 70 participants will be recruited for a first visit, when they will give informed consent. Also at the first visit, medical reports will be confirmed by each participant, anthropometric measures will be recorded and blood samples will be collected. After first blood analysis results, participants with stable parameters will be called for a second visit when they will be enrolled in a randomized, placebo-controlled, crossover trial, with 4 treatment periods of 6 weeks each, corresponding to a total of 7 visits. At each visit, blood samples and anthropometric measures will be collected. At the first intervention period, study participants will receive a packaged for the functional or control treatment. Functional treatment packaged will be composed by omega 3 softgels (fish oil), chocolate containing plant sterols and green tea. Control treatment will be composed by soy oil softgels, regular chocolate, and anise tea. Subjects will be advised to consume 3 softgels and 1 chocolate twice a day, after main meals, and to drink two cups of tea per day. After a 6-weeks washout period (third visit), the groups will be switched (crossover) and participants will receive the functional or control treatment for more 6 weeks (fourth visit). After biomarkers evaluation, the subjects with the greatest response to the functional treatment will be selected for additional 6 weeks of functional intervention associated to a reduction of the hypolipidaemic drugs (statin) dosage, which will be prescribed individually and by the evaluation of the responsible physician.
- Conditions
- Cardiovascular Diseases
- Being tested
- Functional treatment, Control treatment
- Keywords
- Atherosclerosis, omega 3, plant sterols, polyphenols
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional treatmentDietary supplement
Omega 3 fatty acids, plant sterols and polyphenols
Control treatmentDietary supplement
placebo supplements
| Study group | Role | What they receive |
|---|---|---|
| Functional treatment | Experimental | Daily functional treatment consisted of seven fish oil softgels (1.7g EPA+DHA), two dark chocolate truffles containing plant sterol esters and two green tea sachets. Receives: Dietary Supplement: Functional treatment |
| Control treatment | Placebo comparator | Control treatment consisted of seven soy bean oil softgels, two regular dark chocolate truffles and two anise tea sachets Receives: Dietary Supplement: Control treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL
Measured: after 6 weeks of supplementation
C-reactive protein
Measured: after 6 weeks of supplementation
Malondialdehyde
Measured: after 6 weeks of supplementation
Secondary outcomes (3)
Omega 3 fatty acids profile
plasma samples
Measured: after 6 weeks of supplementation
Cholesterol synthesis and absorption markers
plasma samples
Measured: after 6 weeks of supplementation
Antioxidant enzymes activity
Lysates samples
Measured: after 6 weeks of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Bertolami, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732223
- Sponsor's protocol ID
- NºCAAE 27349114.5.3001.0067
- Status last verified
- Apr 2016
- First submitted
- 4 Apr 2016
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Scolaro B, Nogueira MS, Paiva A, Bertolami A, Barroso LP, Vaisar T, Heffron SP, Fisher EA, Castro IA. Statin dose reduction with complementary diet therapy: A pilot study of personalized medicine. Mol Metab. 2018 May;11:137-144. doi: 10.1016/j.molmet.2018.02.005. Epub 2018 Feb 20.
PubMed 29503145
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Therapy of Omega 3 Fatty Acids, Plant Sterols and Polyphenols Over Cardiovascular Markers in Statin Treated Patients
- ClinicalTrials.gov ID
- NCT02732223
- Acronym / sponsor ID
- NºCAAE 27349114.5.3001.0067
- Conditions
- Cardiovascular Diseases
- Keywords
- Atherosclerosis, omega 3, plant sterols, polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Apr 2016 (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.
Atherosclerosis, one major cause of morbidity and mortality worldwide, is a complex and multifactorial disease triggered especially due to high level of plasma lipids and that involves three mainly conditions: chronic inflammation, dyslipidemia and oxidative stress. Taking into account the high costs of disease management, eminent suboptimal response and low compliance to drug therapies, the combined use of natural bioactive compound able to reduce atherosclerosis risk could provide an additional protection. In this study, the effects of three bioactive components, namely omega-3 fatty acids, plants sterols and polyphenols present in green tea, will be evaluated over atherosclerosis biomarkers in individuals with dyslipidemia controlled by drugs. It will be carried out a randomized, double-blind, placebo-controlled, crossover clinical study, with participation of 70 subjects. At each intervention period, study participants will receive a packaged for the functional or placebo treatment. Functional treatment packaged will be composed by omega 3 softgels (fish oil), a chocolate containing plant sterols and green tea. Placebo treatment will be composed by corn oil softgels, regular chocolate, and anise tea. Subjects will be advised to consume the softgels and chocolate twice a day after main meals and to drink two cups of tea per day. After evaluation of inflammation, dyslipidemia and oxidative stress biomarkers, subjects with the greatest response to the functional treatment will be selected for additional 6 weeks of functional intervention associated to a reduction of the hypolipidaemic drugs intake, which will be prescribed individually after evaluation of the responsible physician.
Detailed description
From eligible subjects, 70 participants will be recruited for a first visit, when they will give informed consent. Also at the first visit, medical reports will be confirmed by each participant, anthropometric measures will be recorded and blood samples will be collected. After first blood analysis results, participants with stable parameters will be called for a second visit when they will be enrolled in a randomized, placebo-controlled, crossover trial, with 4 treatment periods of 6 weeks each, corresponding to a total of 7 visits. At each visit, blood samples and anthropometric measures will be collected. At the first intervention period, study participants will receive a packaged for the functional or control treatment. Functional treatment packaged will be composed by omega 3 softgels (fish oil), chocolate containing plant sterols and green tea. Control treatment will be composed by soy oil softgels, regular chocolate, and anise tea. Subjects will be advised to consume 3 softgels and 1 chocolate twice a day, after main meals, and to drink two cups of tea per day. After a 6-weeks washout period (third visit), the groups will be switched (crossover) and participants will receive the functional or control treatment for more 6 weeks (fourth visit). After biomarkers evaluation, the subjects with the greatest response to the functional treatment will be selected for additional 6 weeks of functional intervention associated to a reduction of the hypolipidaemic drugs (statin) dosage, which will be prescribed individually and by the evaluation of the responsible physician.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional treatment | Experimental | Dietary Supplement: Functional treatmentDaily functional treatment consisted of seven fish oil softgels (1.7g EPA+DHA), two dark chocolate truffles containing plant sterol esters and two green tea sachets. |
| Control treatment | Placebo comparator | Dietary Supplement: Control treatmentControl treatment consisted of seven soy bean oil softgels, two regular dark chocolate truffles and two anise tea sachets |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The primary selection criteria were current statin (simvastatin or atorvastatin) and hypoglycemic treatment (metformin and/or gliclazide).
Key exclusion criteria (1 listed)
- Exclusion criteria were patients who were taking omega 3 fatty acids, plant sterol or green tea supplements; uncontrolled diabetes (HbA1c > 7.5%) or dyslipidemia (LDL-C > 100 mg/dL); pregnant females; and patients who presented any congenital cardiac disorders, uncontrolled endocrine, renal or hepatic disease and excessive alcohol consumption.
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 |
|---|---|---|
| Functional treatmentOmega 3 fatty acids, plant sterols and polyphenols | Dietary supplement | Functional treatment |
| Control treatmentplacebo supplements | Dietary supplement | Control treatment |
Primary outcome
LDL
Time frame: after 6 weeks of supplementation
C-reactive protein
Time frame: after 6 weeks of supplementation
Malondialdehyde
Time frame: after 6 weeks of supplementation
3 secondary outcomes
Omega 3 fatty acids profile
Time frame: after 6 weeks of supplementation
Cholesterol synthesis and absorption markers
Time frame: after 6 weeks of supplementation
Antioxidant enzymes activity
Time frame: after 6 weeks of supplementation
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 8 Apr 2016.
- Derived from this study: PubMed 29503145Scolaro B, Nogueira MS, Paiva A, Bertolami A, Barroso LP, Vaisar T, Heffron SP, Fisher EA, Castro IA. Statin dose reduction with complementary diet therapy: A pilot study of personalized medicine. Mol Metab. 2018 May;11:137-144. doi: 10.1016/j.molmet.2018.02.005. Epub 2018 Feb 20.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Functional treatment in people with Cardiovascular Diseases, run by Instituto Dante Pazzanese de Cardiologia.
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 1 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 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
LDL (time frame: after 6 weeks of supplementation). The study lists 3 primary outcomes in all. 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 NCT02732223, which also lists 1 linked publication.
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 8 Apr 2016.