Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans
Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of SDA-rich Echium Oil in Humans Depending on Age, Gender and Physiological Stage
1 other identifier
interventional
78
1 country
1
Brief Summary
The objective of this study is to investigate the conversion of the precursors ALA and SDA into n-3 LC-PUFA (EPA, DPA and DHA) in humans by oral supplementation of Echium oil in comparison with SDA soybean oil (positive control). In addition, the accumulation of n-3 LC-PUFA is compared between subpopulations of different age, gender and physiological conditions (overweight, increased serum total cholesterol).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Mar 2011
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 29, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2013
CompletedMay 17, 2013
May 1, 2013
5 months
November 29, 2011
May 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
eicosapentaenic acid
eicosapentaenic acid in lipids of plasma, erythrocytes and peripheral mononuclear cells (% of total identified fatty acid methyl esters)
after 0,7, 56 days
Secondary Outcomes (1)
Lipid mediators derived from AA, EPA and DGLA such as HETE species (5-HETE; 8-HETE, etc.)
0 and 56 days
Study Arms (3)
Echium oil young
EXPERIMENTALBMI\<25, age 20-30
Echium oil older
EXPERIMENTALage 40-70 BMI \<25
Echium oil older, overweight
EXPERIMENTALage 40-70 BMI \>25
Interventions
Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)
Eligibility Criteria
You may qualify if:
- healthy subjects
You may not qualify if:
- cholesterol lowering drugs
- chronic diseases
- pregnancy, lactation
- intake of nutritional supplements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Jenalead
- German Research Foundationcollaborator
Study Sites (1)
Friedrich Schiller University of Jena
Jena, Thuringia, 07743, Germany
Related Publications (2)
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.
PMID: 26892399DERIVEDKuhnt K, Fuhrmann C, Kohler M, Kiehntopf M, Jahreis G. Dietary echium oil increases long-chain n-3 PUFAs, including docosapentaenoic acid, in blood fractions and alters biochemical markers for cardiovascular disease independently of age, sex, and metabolic syndrome. J Nutr. 2014 Apr;144(4):447-60. doi: 10.3945/jn.113.180802. Epub 2014 Feb 19.
PMID: 24553695DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katrin Kuhnt, Dr. rer. nat
University of Jena, Insitute of Nutrition
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. habil.
Study Record Dates
First Submitted
November 29, 2011
First Posted
May 17, 2013
Study Start
March 1, 2011
Primary Completion
August 1, 2011
Study Completion
April 1, 2012
Last Updated
May 17, 2013
Record last verified: 2013-05