NCT02732223

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started May 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
Last Updated

April 8, 2016

Status Verified

April 1, 2016

Enrollment Period

7 months

First QC Date

April 4, 2016

Last Update Submit

April 7, 2016

Conditions

Cardiovascular Diseases

Keywords

Atherosclerosisomega 3plant sterolspolyphenols

Outcome Measures

Primary Outcomes (3)

  • LDL

    after 6 weeks of supplementation

  • C-reactive protein

    after 6 weeks of supplementation

  • Malondialdehyde

    after 6 weeks of supplementation

Secondary Outcomes (3)

  • Omega 3 fatty acids profile

    after 6 weeks of supplementation

  • Cholesterol synthesis and absorption markers

    after 6 weeks of supplementation

  • Antioxidant enzymes activity

    after 6 weeks of supplementation

Study Arms (2)

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.

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

Dietary Supplement: Control treatment

Interventions

Functional treatmentDIETARY_SUPPLEMENT

Omega 3 fatty acids, plant sterols and polyphenols

Functional treatment
Control treatmentDIETARY_SUPPLEMENT

placebo supplements

Control treatment

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29503145DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. PhD

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

April 8, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share