Combined Bioactive Therapy Effects Over Cardiovascular Markers in Statin Treated Patients

NCT ID: NCT02732223

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-12-31

Brief 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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

Functional treatment

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.

Group Type: EXPERIMENTAL

Functional treatment

Intervention Type: DIETARY_SUPPLEMENT

Omega 3 fatty acids, plant sterols and polyphenols

Control treatment

Control treatment consisted of seven soy bean oil softgels, two regular dark chocolate truffles and two anise tea sachets

Group Type: PLACEBO_COMPARATOR

Control treatment

Intervention Type: DIETARY_SUPPLEMENT

placebo supplements

Interventions

Functional treatment

Omega 3 fatty acids, plant sterols and polyphenols

Intervention Type: DIETARY_SUPPLEMENT

Control treatment

placebo supplements

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role: lead

Responsible Party

Adriana Bertolami

MD. PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 29503145 (View on PubMed)

Other Identifiers

NºCAAE 27349114.5.3001.0067

Identifier Type: -

Identifier Source: org_study_id