- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01690312
Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy
Clinical Study to Assess the Acute and Chronic Effects of a High-DHA Fish Oil on Fasting and Post-Prandial Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study involves fasted and post-prandial components.
Fasted Study:
Participants will provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo] in Treatment Period I. Participants will again provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo, opposite to Treatment Period I] during Treatment Period II.
There will be a 4-week washout period during the two Treatment Periods.
Post-prandial study:
Participants will also complete a post-prandial study pre-and post-intervention during each Treatment Period.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ontario
-
Guelph, Ontario, Canada, N1G 0B4
- Nutrasource Diagnostics Inc.
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Be an adult between the ages of 18 and 70;
- Be a male or a post-menopausal female who has gone a minimum of one year since their last menses;
- Be taking Statin medication at a stable dose for a minimum of four weeks prior to study commencement [and whom have reached a target LDL level];
- Have elevated fasting triglyceride levels [greater than 1.5 mmol/L but less than 5.7 mmol/L];
- Have fasting blood glucose levels below the study cut-off [less than 7.0 mmol/L];
- Have a Body Mass Index (BMI) less than 35.0
- Be taking natural health products BUT agree to cease consumption during the study period and a 4-week pre-study washout prior to study commencement. Study participants will be allowed to consume a daily multivitamin if they have been doing so at a stable dose for a minimum of three months prior to study commencement.
Exclusion Criteria:
- Be younger than 18 years of age or older than 70 years of age;
- Be an adult pre- or peri-menopausal female;
- Not have taken Statin medication at a stable dose for a minimum of 4 weeks prior to study commencement;
- Have fasting triglyceride levels outside of study limits[ie/ less than 1.5 mmol/L or greater than 5.7 mmol/L];
- Have elevated fasting blood glucose levels [greater or equal to 7.0 mmol/L];
- Have high blood pressure [greater than 140/100]
- Have a Body Mass Index (BMI) equal to or greater than 35.0
- Have a pre-existing cardiovascular disease or illness, including angina, myocardial infarction, stroke, intermittent claudication or transient ischemic attack;
- Have a known allergy to fish and/or fish oil, olive oil, soy or Vitamin E;
- Be taking natural health products but are unwilling to cease consumption during the study period and a 4-week pre-study washout prior to study commencement;
- Consume more than two (2) fish meals on a weekly basis
- Consume excessive amounts of alcohol on a weekly basis [more than 10 alcoholic drinks per week];
- Anticipate or have planned surgery during the course of the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1 (Dietary Supplement - Fish Oil)
On Day 1 & Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed. On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol. |
On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day.
Each capsule contains 1000 mg of fish oil [620 mg of DHA and 150 mg of EPA], providing a total daily dosage of 4000 mg of fish oil [3080 mg of DHA+EPA].
|
Eksperimentell: 2 (Placebo)
On Day 1 & Day 29, the researcher will obtain anthropometric measurements as specified in the study protocol. A venous catheter will be inserted and a fasted blood sample will be drawn, which will be analyzed for study primary and secondary endpoints. Participants will consume a Breakfast Meal (which will represent t0) and will have blood drawn at a total of 7 time points. Blood samples drawn at30, t60, t120, and t180 will be analyzed for glucose and insulin; blood samples drawn at t60, t120, t180, t240, t300 and t360 will be analyzed for triglycerides. Upon completion of the 6 hour blood draw period, the venous catheter will be removed. On Day 15, the researcher will obtain anthropometric measurements as specified in the study protocol. |
On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day.
Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Triglyceride [TG]
Tidsramme: 0 and 4 weeks
|
Fasted and postprandial samples will be drawn (hourly up to 6 hours).
|
0 and 4 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Glucose
Tidsramme: 0 and 4 weeks
|
Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
|
0 and 4 weeks
|
Insulin
Tidsramme: 0 and 4 weeks
|
Fasted and postprandial samples will be drawn (every 30 minutes up to 2 hours).
|
0 and 4 weeks
|
Total cholesterol [TC]
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
High-density lipoprotein [HDL]
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Low-density lipoprotein [LDL]
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Very low-density lipoprotein [VLDL]
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Lipoprotein A
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Intermediate-density lipoprotein [IDL]
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Remnant Lipoproteins
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
High-sensitivity C-Reactive Protein [hs-CRP]
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Homocysteine
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Essential Fatty Acid Profile
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Apolipoprotein B
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Apolipoprotein A-1
Tidsramme: 0 and 4 weeks
|
A fasted blood sample will be taken.
|
0 and 4 weeks
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Alison Duncan, Ph.D., R.D., University of Guelph
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- Insulin
- Mennesker
- Hjerte-og karsykdommer
- DHA
- Fiskeolje
- Statiner
- Glukose
- Triglyserider
- Post-Prandial
- Homocystein
- EPA
- Lipoproteiner
- Fastet
- Apolipoprotein B
- High-DHA
- Total cholesterol [TC]
- High-density lipoprotein [HDL2, HDL3]
- Low-density lipoprotein [LDL1+2+3+4]
- Lipoprotein A [Lp(a)]
- Intermediate-density lipoprotein (IDL)
- Very low-density lipoprotein (VLDL1+2, VLDL3)
- Remnant Lipoproteins
- High-sensitivity C-Reactive Protein [hs-CRP]
- Essential Fatty Acid Profile
- Apolipoprotein A-1
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 11-09-002
- 150038 (Health Canada)
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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