- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01517685
Hallelujah Acres Omega 3 Fat Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is being conducted to compare the response of individuals to flax seed oil or fish oil, measured by blood lipids. Especially the amount of the long chain omega 3 polyunsaturated fats EPA and DHA will be tested. An omega 3 score for whole blood will be measured. The omega 3 score is the percent sum of omega 3 fats in the blood.
The hypothesis is that 5 grams of fish oil will increase the amount of EPA and DHA in a person's blood to a protective level, and that 30 grams (2 tablespoons) of flax oil will not change the blood levels of EPA significantly and not change the blood concentrations of DHA at all, even for a person consuming a low omega 6 oil diet and following a vegan diet high in fruits and vegetables.
Most of the testing of flax and fish oil has not been done in vegans. This trial will extend this testing to this subpopulation.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Washington
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Zillah, Washington, Forenede Stater, 98953
- Hallelujah Acres Research Office / Laboratory
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Must have followed the Hallelujah Diet (or very similar diet) for at least the last two years,
- Must have stable body weight (not gained or lost more than 5 pounds of weight over the last three months)
Exclusion Criteria:
- Pregnancy (all pregnant women should take fish oil, not flax seed oil)
- Currently using fish oil, or flax seed oil,EPA, DHA, or flax seed oil with added DHA
- Eating more than 2 teaspoons of flax seed per day
- Diabetes (fish oil may affect blood sugar levels)
- Generally poor health
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Flax Oil and then Fish Oil
All people in the study will use the flax seed oil and then the fish oil.
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2 tablespoons of organic flax seed oil are eaten daily for 8 weeks.
Andre navne:
5 grams (1 tsp.) of fish oil is eaten per day for 8 weeks.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Omega 3 Score
Tidsramme: 8 weeks of supplementation before testing
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A finger prick blood sample is analyzed for fatty acids, including the amount of omega 3 fats in the blood.
The Omega 3 Score is the amount of EPA and DHA in whole blood as a percent of fat.
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8 weeks of supplementation before testing
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Michael Donaldson, PhD, Hallelujah Acres
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 20111700
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-
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USDA Grand Forks Human Nutrition Research CenterUnited States Department of Agriculture (USDA); University of North DakotaAfsluttetOmega-3 fedtsyrer | LipidperoxidationForenede Stater
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University of GuelphUkendtEffekt af Omega-3 fedtsyretilskud Fysisk konditionCanada
-
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-
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Kliniske forsøg med Organic flax seed oil
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