Combined Bioactive Therapy Effects Over Cardiovascular Markers in Statin Treated Patients
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

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.
      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.
    

Intervention name(s): Functional treatment; Control treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Omega 3 fatty acids, plant sterols and polyphenols; placebo supplements
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Atherosclerosis; omega 3; plant sterols; polyphenols