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.
1 other identifier
interventional
78
1 country
1
Brief Summary
The objective of this study is to investigate the accumulation of n-3 LC-PUFA (EPA, DPA and DHA) in human lipids by oral supplementation of ALA-rich linseed oil. 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 Feb 2012
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
First Submitted
Initial submission to the registry
March 16, 2011
CompletedFirst Posted
Study publicly available on registry
March 17, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedNovember 13, 2013
November 1, 2013
7 months
March 16, 2011
November 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
n-3 LC-PUFA in human lipids (EPA)
EPA (% of total identified fatty acid methyl esters)
0,7,56 days
Secondary Outcomes (1)
eicosanoid concentration in plasma
0 and 56 days
Study Arms (4)
linseed oil; young
EXPERIMENTALALA rich linseed oil to younger subjects (18-35 years)
linseed oil; older
EXPERIMENTALALA rich linseed oil to older, normalweight subjects (BMI \<25, age 49-69 years)
linseed oil older, overweight
EXPERIMENTALALA-rich linseed oil to older, normalweight subjects (BMI \>25, age 49-69 years)
olive oil
EXPERIMENTALn3-PUFA free control oil to normalweight subjects (BMI \<25)
Interventions
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: 26892399DERIVEDGrindel 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.
PMID: 24229084DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
March 16, 2011
First Posted
March 17, 2011
Study Start
February 1, 2012
Primary Completion
September 1, 2012
Study Completion
May 1, 2013
Last Updated
November 13, 2013
Record last verified: 2013-11