- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01317290
Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans (ALA_KK)
Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of ALA-rich Oil in Humans Depending on Age, Gender and Physiological Stage.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
N-3 PUFA are important for human health and nutrition. Unfortunately, the land-based n-3 ALA is a limited precursor for the formation of n-3 LC-PUFA. The conversion of ALA depends on the rate-limiting ∆6-desaturation.
The first objective of this study is to investigate differences of the accumulation of n-3 LC-PUFA (EPA, DPA and DHA) in human lipids during supplementation of ALA-rich linseed oil dependent on age, gender and physiological conditions (overweight, increased serum total cholesterol). One study group will receive fish oil with mainly EPA as positive control.
The second objective is to compare the n-3 LC-PUFA enrichment during the linseed oil supplementation (study LSEP H50-KK) with the n-3 LC-PUFA enrichment during the further Echium oil supplementation (study LSEP H42-KK). The second study will be the control for the first study.
Therefore, it is planned to recruit the same subjects for the linseed oil supplementation.
Eighty volunteers will be recruited and allocated into four study groups depending on age and BMI. Three groups (each n=20) will receive daily ca. 15 g linseed oil (mean age: 25 and 55 years; mean BMI < 25; and mean age 55 and BMI > 25). One group (n=20) will receive n-3PUFA free olive oil (mean age 25 and 55, BMI < 25). The double-blind, randomized, parallel-designed study will start with a two-weeks run-in period, followed by an eight-weeks supplementation period. After the run-in period, one week and eight weeks of oil supplementation blood will be drawn and 24-h urine will be sampled.
Altogether, the fatty acid distribution after Echium oil and linseed oil supplementation from similar subjects can be statistically analysed.
Studietype
Registrering (Faktiske)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
-
-
Thuringia
-
Jena, Thuringia, Tyskland, 07743
- Friedrich Schiller University of Jena
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- cholesterol lowering drugs
- chronic diseases
- pregnancy, lactation
- intake of nutritional supplements
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: linseed oil; young
ALA rich linseed oil to younger subjects (18-35 years)
|
|
|
Eksperimentell: linseed oil; older
ALA rich linseed oil to older, normalweight subjects (BMI <25, age 49-69 years)
|
|
|
Eksperimentell: linseed oil older, overweight
ALA-rich linseed oil to older, normalweight subjects (BMI >25, age 49-69 years)
|
|
|
Eksperimentell: olive oil
n3-PUFA free control oil to normalweight subjects (BMI <25)
|
negative control
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
n-3 LC-PUFA in human lipids (EPA)
Tidsramme: 0,7,56 days
|
EPA (% of total identified fatty acid methyl esters)
|
0,7,56 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
eicosanoid concentration in plasma
Tidsramme: 0 and 56 days
|
0 and 56 days
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Katrin Kuhnt, Dr. rer. nat, University of Jena, Insitute of Nutrition
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kuhnt K, Weiss S, Kiehntopf M, Jahreis G. Consumption of echium oil increases EPA and DPA in blood fractions more efficiently compared to linseed oil in humans. Lipids Health Dis. 2016 Feb 18;15:32. doi: 10.1186/s12944-016-0199-2.
- Grindel A, Staps F, Kuhnt K. Cheek cell fatty acids reflect n-3 PUFA in blood fractions during linseed oil supplementation: a controlled human intervention study. Lipids Health Dis. 2013 Nov 14;12:173. doi: 10.1186/1476-511X-12-173.
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H50-11-KK
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