- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
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Thuringia
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Jena, Thuringia, Allemagne, 07743
- Friedrich Schiller University of Jena
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- cholesterol lowering drugs
- chronic diseases
- pregnancy, lactation
- intake of nutritional supplements
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: linseed oil; young
ALA rich linseed oil to younger subjects (18-35 years)
|
|
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Expérimental: linseed oil; older
ALA rich linseed oil to older, normalweight subjects (BMI <25, age 49-69 years)
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|
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Expérimental: linseed oil older, overweight
ALA-rich linseed oil to older, normalweight subjects (BMI >25, age 49-69 years)
|
|
|
Expérimental: olive oil
n3-PUFA free control oil to normalweight subjects (BMI <25)
|
negative control
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
n-3 LC-PUFA in human lipids (EPA)
Délai: 0,7,56 days
|
EPA (% of total identified fatty acid methyl esters)
|
0,7,56 days
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
eicosanoid concentration in plasma
Délai: 0 and 56 days
|
0 and 56 days
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Katrin Kuhnt, Dr. rer. nat, University of Jena, Insitute of Nutrition
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- H50-11-KK
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