- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00781950
Effects of Dietary Flaxseed on Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease (FLAXPAD)
27. oktober 2016 oppdatert av: Dr. Grant Pierce
A Double Blind, Randomized, Placebo Controlled, Study for Assessment of Dietary Flaxseed on Improving Symptoms of Cardiovascular Disease in Patients With Peripheral Arterial Disease
This Clinical Trial is being conducted to study how patients with peripheral arterial disease (a condition in which the blood vessels of the extremities are affected) respond to a dietary regimen of flaxseed.
The purpose of the study is to examine whether or not dietary flaxseed have any effect on improving symptoms of cardiovascular disease.
Additionally, the effects of dietary flaxseed on exercise tolerance will be assessed.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The proposed trial is a one year, double blinded, placebo controlled study designed to examine and compare the effects of dietary ground flaxseed supplementation in volunteers with claudication secondary to lower extremity atherosclerotic arterial disease (peripheral arterial disease).
The original proposal was for a two year study duration but this was truncated at one year to insure patient compliance remained high.
This patient population is likely to benefit from flaxseed because there is a high prevalence of accelerated atherosclerosis and a higher than normal incidence of arrhythmias, myocardial infarctions and stroke.
This study will be focus on whether dietary flaxseed can reduce clinical manifestations of peripheral arterial disease and increase exercise capacity in these patients.
Two general hypotheses will be tested in this proposal.
First, we hypothesize that fewer primary and secondary events (all-cause mortality, cardiovascular mortality, stroke, myocardial infarctions, angina, arrhythmias) will occur in patients who ingest flaxseed in their diet.
Secondly, we hypothesize that dietary flaxseed supplementation will be associated with beneficial effects on exercise performance, blood pressure and circulating lipid levels.
This trial will generate data on the safety, tolerability, cardiovascular efficacy and genomic response to a diet rich in flaxseed in patients with peripheral arterial disease (PAD).
Studietype
Intervensjonell
Registrering (Faktiske)
110
Fase
- Fase 2
- Fase 3
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 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects with peripheral arterial disease for more than 6 months.
- Male or female with claudication secondary to lower extremity atherosclerotic arterial disease. (with limited IC but not incapacitated for walking on the level) confirmed with ankle/brachial pressures< or = to 0.9 in one or both legs) or who have had a previous intervention for peripheral arterial disease.
- Over 40 years old
- Able to comply with protocol requirements
- Able to provide informed consent
- Subjects taking anti-platelet therapy medication must be on a stable dose for 3 months prior to as well as during the study.
- Subjects taking lipid lowering medication must be on a stable dose for 3 months prior to as well as during the study.
Exclusion Criteria:
- Patients with ischemic rest pain in limbs, ulceration, or gangrene.
- At baseline, any condition that prevents walking on a treadmill.
- History of major bleeding.
- Patients with bowel disease (including Crohn's disease, celiac disease, peptic ulcer disease, irritable bowel syndrome and diverticulosis).
- Patients with an estimated life expectancy less than 2 years and with high baseline cardiac risk (post ischemic or diabetic cardiomyopathy with EF<40%, Canadian Cardiovascular Society Class 3 or 4 angina or need for coronary revascularization procedures).
- Moderate to severe renal failure.
- Subjects that are on supplements other that those prescribed by their clinician for the entire duration of the study.
- Fish limitations (no more than 2 fish meals per week)
- Gluten allergy
- Subjects with allergies to any ingredient in the study product or placebo.
- Patients who plan to undergo surgery during the course of the trial.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
Randomized, Blinded Controlled Arm of patients receiving placebo food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing a mixture of wheat and wheat bran to replace the flaxseed daily for one year.
|
Wheat and Mixed Dietary Oils
|
Eksperimentell: Flaxseed
Randomized, Blinded group of patients that will be given food products (ie: bagels, muffins, bars, pasta, buns, and milled seeds) containing 30 g of milled flaxseed daily for one year
|
30 grams of milled flaxseed per day in food products or on its own.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Number of Participants With All-cause Mortality, Cardiovascular Mortality, Stroke, and Myocardial Infarctions
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Effects on Exercise Performance, Blood Pressure and Circulating Lipid Levels.
Tidsramme: 1 year
|
1 year
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Grant Pierce, PhD, University of Manitoba
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.
Generelle publikasjoner
- Caligiuri SP, Rodriguez-Leyva D, Aukema HM, Ravandi A, Weighell W, Guzman R, Pierce GN. Dietary Flaxseed Reduces Central Aortic Blood Pressure Without Cardiac Involvement but Through Changes in Plasma Oxylipins. Hypertension. 2016 Oct;68(4):1031-8. doi: 10.1161/HYPERTENSIONAHA.116.07834. Epub 2016 Aug 15.
- Edel AL, Rodriguez-Leyva D, Maddaford TG, Caligiuri SP, Austria JA, Weighell W, Guzman R, Aliani M, Pierce GN. Dietary flaxseed independently lowers circulating cholesterol and lowers it beyond the effects of cholesterol-lowering medications alone in patients with peripheral artery disease. J Nutr. 2015 Apr;145(4):749-57. doi: 10.3945/jn.114.204594. Epub 2015 Feb 18.
- Caligiuri SP, Aukema HM, Ravandi A, Guzman R, Dibrov E, Pierce GN. Flaxseed consumption reduces blood pressure in patients with hypertension by altering circulating oxylipins via an alpha-linolenic acid-induced inhibition of soluble epoxide hydrolase. Hypertension. 2014 Jul;64(1):53-9. doi: 10.1161/HYPERTENSIONAHA.114.03179. Epub 2014 Apr 28.
Hjelpsomme linker
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. oktober 2008
Primær fullføring (Faktiske)
1. mars 2011
Studiet fullført (Faktiske)
1. oktober 2016
Datoer for studieregistrering
Først innsendt
28. oktober 2008
Først innsendt som oppfylte QC-kriteriene
28. oktober 2008
Først lagt ut (Anslag)
29. oktober 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
12. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. oktober 2016
Sist bekreftet
1. oktober 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10941-011
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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