Combined Bioactive Therapy Effects Over Cardiovascular Markers in Statin Treated Patients

Cardiovascular Diseases Clinical Trial

Official title:

Complementary Therapy of Omega 3 Fatty Acids, Plant Sterols and Polyphenols Over Cardiovascular Markers in Statin Treated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732223
• Other study ID #: NºCAAE 27349114.5.3001.0067
• Status: Completed
• Phase: N/A
• First received: April 4, 2016
• Last updated: April 7, 2016
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Instituto Dante Pazzanese de Cardiologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• The primary selection criteria were current statin (simvastatin or atorvastatin) and hypoglycemic treatment (metformin and/or gliclazide).

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Dietary Supplement:
• Functional treatment
Omega 3 fatty acids, plant sterols and polyphenols
• Control treatment
placebo supplements

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Dante Pazzanese de Cardiologia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL		after 6 weeks of supplementation	No
Primary	C-reactive protein		after 6 weeks of supplementation	No
Primary	Malondialdehyde		after 6 weeks of supplementation	No
Secondary	Omega 3 fatty acids profile	plasma samples	after 6 weeks of supplementation	No
Secondary	Cholesterol synthesis and absorption markers	plasma samples	after 6 weeks of supplementation	No
Secondary	Antioxidant enzymes activity	Lysates samples	after 6 weeks of supplementation	No