Intervention With Omega Fatty Acids in High-risk Patients
19. desember 2016 oppdatert av: Haukeland University Hospital
Intervention With Omega Fatty Acids in High-risk Patients With Hypertriglyceridemic Waist
In order to reduce cardiovascular risk, current European guidelines recommend a diet low on saturated fatty acid through replacement with polyunsaturated fatty acids (PUFA).
Polyunsaturated fatty acids can be classified into omega-3 and omega-6.
However the results from recent meta-analyses investigating coronary risk outcomes did not clearly support a low intake of saturated fatty acids and a high intake of omega-3 or omega-6.
The aim of this study is to investigate the short term effects of a high intake of PUFAs on microvascular function, lipids, inflammation and other cardiovascular risk factors in inactive patients with increased waistline.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 2
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
30 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Waist circumference ≥ 94 cm in men and ≥ 80 cm in women
- Physical inactivity (< 2 h vigorous/active exercise training per week)
Exclusion Criteria:
- Regular use of certain prescription medications at baseline
- Severe psychiatric illness
- Pregnancy
- Pacemaker or implantable cardioverter defibrillator
- Cigarette smoking
- Previous coronary intervention
- Concomitant use of dietary supplements
- Use of omega-3 supplements at baseline
- Alcohol or drug abuse or any condition associated with poor compliance.
- Scheduled hospitalisation during the course of the study.
- Participation in a clinical trial in the last 12 weeks, or prior randomisation.
- Blood donation within the preceding 12 weeks.
- Diabetes Mellitus Type 1 or type 2
- Triglycerides > 5 mmol/l
- Previous bariatric surgery
- Malabsorption disorder
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Omega-3 fatty acid
Omega-3 fatty acids for 8 weeks, dosage are 3 and 4 g/day for women and men, respectively.
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Experimental: Omega-3 fatty acid In the intervention period the participants will receive a daily supplement of omega-3 fatty acids for 8 weeks, where the dosage are 3 and 4 g/day for women and men, respectively.
The omega-3 supplement is a hydrolyzed and reesterified TAG fish oil, containing 33 area percent eicosapentaenoic acid and 22 area percent docosahexaenoic acid.
Andre navn:
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Eksperimentell: Omega-6 fatty acid
Omega-6 fatty acids for 8 weeks, dosage are 20 and 27 g/day for women and men, respectively.
|
Experimental: Omega-6 fatty acid In the intervention period the participants will receive a daily supplement of omega-6 fatty acid for 8 weeks, where the dosage are 20 and 27 g/day for women and men, respectively.
The omega-6 supplement is a high-quality organic, cold pressed and filtered safflower oil, containing 68-83% linoleic acid, 5-15% saturated fatty acid, 8-21% oleic acid, 0,0-0,5% ALA and maximum 2% other fatty acids.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in lipid profile
Tidsramme: Measured at baseline and after 8 weeks
|
High-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol and triglycerides (TG) will be measured in plasma/serum (mmol/L).
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Measured at baseline and after 8 weeks
|
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Changes in particle concentrations of lipoproteins of different sizes
Tidsramme: Measured at baseline and week 8
|
Particle concentration (nmol/L) of lipoprotein of different sizes will be calculated from the measured amplitude of their spectroscopically lipid methyl group NMR signals.
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Measured at baseline and week 8
|
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Changes in lipoprotein particle sizes
Tidsramme: Measured at baseline and week 8
|
Lipoprotein particle size (nm) analysis will be performed by proton nuclear magnetic resonance (NMR) spectroscopy.
The size will be derived from the sum of diameter of each subclass multiplied by its relative mass percentage based on its methyl NMR signal.
|
Measured at baseline and week 8
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in body composition
Tidsramme: Measured at baseline and week 8
|
Body composition will be measured by bioelectrical impedance (InBody 720).
|
Measured at baseline and week 8
|
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Changes in body weight
Tidsramme: Measured at baseline and week 8
|
Measured at baseline and week 8
|
|
|
Changes in waist and hip circumference
Tidsramme: Measured at baseline and week 8
|
Measured at baseline and week 8
|
|
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Changes in circulating markers of inflammation, also including adipokines and kynurenine
Tidsramme: Measured at baseline and week 8
|
Inflammatory markers and adipokines will be measured in serum/plasma, e.g tumor necrosis factor-α (TNF-α), interleukins, macrophage inflammatory protein 1-α (MIP-1-α) and granulocyte-macrophage colony stimulating factor (GM-CSF).
|
Measured at baseline and week 8
|
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Changes in markers of inflammation in adipose tissue
Tidsramme: Measured at baseline and week 8
|
Inflammatory markers like TNF-α, interleukins, GM-CSF and adiponectin in will be measured in adipose tissue (pg/mg tissue).
|
Measured at baseline and week 8
|
|
Changes in one carbon metabolites
Tidsramme: Measured at baseline and week 8
|
Choline, betaine and related metabolites and B-vitamins involved in 1-carbon metabolism.
|
Measured at baseline and week 8
|
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Changes in microbiota
Tidsramme: Measured at baseline and week 8
|
Bacterial DNA in stool samples will be subjected to high-throughput barcode multiplex sequencing of the 16s ribosomal RNA gene (rRNA).
|
Measured at baseline and week 8
|
|
Changes in endothelial function
Tidsramme: Measured at baseline and week 8
|
Vascular reactivity index (VRI) will be measured by monitoring fingertip temperature changes during a reactive hyperemia protocol.
|
Measured at baseline and week 8
|
|
Changes in carnitine and metabolites
Tidsramme: Measured at baseline and week 8
|
Trimethylamine N-oxide (TMAO), carnitine, acylcarnitines and fatty acids will be measured in serum/plasma.
|
Measured at baseline and week 8
|
|
Changes in gene expression in adipose tissue
Tidsramme: Measured at baseline and week 8
|
Gene expression in adipose tissue will be measured by microarray and quantitative PCR.
|
Measured at baseline and week 8
|
|
Changes in amino acids
Tidsramme: Measured at baseline and week 8
|
Amino acids, methylated amino acids and metabolites will be measured in serum/plasma.
|
Measured at baseline and week 8
|
|
Changes in gene expression i whole blood
Tidsramme: Measured at baseline and week 8
|
Gene expression in full blood will be measured by quantitative PCR.
|
Measured at baseline and week 8
|
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Changes in apolipoproteins
Tidsramme: Measured at baseline and week 8
|
Apolipoproteins A1, A2, B, C2, C3 and E will be measured in serum by a multiplex kit.
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Measured at baseline and week 8
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Espen Rostrup, MD PhD, Haukeland University Hospital, Department of Heart Disease
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. mars 2015
Primær fullføring (Faktiske)
1. april 2016
Studiet fullført (Faktiske)
1. april 2016
Datoer for studieregistrering
Først innsendt
9. september 2015
Først innsendt som oppfylte QC-kriteriene
4. januar 2016
Først lagt ut (Anslag)
6. januar 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. desember 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. desember 2016
Sist bekreftet
1. desember 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2014/2336
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