- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02732223
Combined Bioactive Therapy Effects Over Cardiovascular Markers in Statin Treated Patients
7. april 2016 oppdatert av: Adriana Bertolami, Instituto Dante Pazzanese de Cardiologia
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
53
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
Omega 3 fatty acids, plant sterols and polyphenols
|
Placebo komparator: Control treatment
Control treatment consisted of seven soy bean oil softgels, two regular dark chocolate truffles and two anise tea sachets
|
placebo supplements
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
LDL
Tidsramme: after 6 weeks of supplementation
|
after 6 weeks of supplementation
|
C-reactive protein
Tidsramme: after 6 weeks of supplementation
|
after 6 weeks of supplementation
|
Malondialdehyde
Tidsramme: after 6 weeks of supplementation
|
after 6 weeks of supplementation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Omega 3 fatty acids profile
Tidsramme: after 6 weeks of supplementation
|
plasma samples
|
after 6 weeks of supplementation
|
Cholesterol synthesis and absorption markers
Tidsramme: after 6 weeks of supplementation
|
plasma samples
|
after 6 weeks of supplementation
|
Antioxidant enzymes activity
Tidsramme: after 6 weeks of supplementation
|
Lysates samples
|
after 6 weeks of supplementation
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2014
Primær fullføring (Faktiske)
1. desember 2014
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
4. april 2016
Først innsendt som oppfylte QC-kriteriene
7. april 2016
Først lagt ut (Anslag)
8. april 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. april 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. april 2016
Sist bekreftet
1. april 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NºCAAE 27349114.5.3001.0067
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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