Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans
Primary Purpose
Hypercholesterolemia, Overweight
Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Echium oil
Sponsored by
About this trial
This is an interventional prevention trial for Hypercholesterolemia focused on measuring Conversion of ALA and SDA, Metabolism of n-3 fatty acids
Eligibility Criteria
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- cholesterol lowering drugs
- chronic diseases
- pregnancy, lactation
- intake of nutritional supplements
Sites / Locations
- Friedrich Schiller University of Jena
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Echium oil young
Echium oil older
Echium oil older, overweight
Arm Description
BMI<25, age 20-30
age 40-70 BMI <25
age 40-70 BMI >25
Outcomes
Primary Outcome Measures
eicosapentaenic acid
eicosapentaenic acid in lipids of plasma, erythrocytes and peripheral mononuclear cells (% of total identified fatty acid methyl esters)
Secondary Outcome Measures
Lipid mediators derived from AA, EPA and DGLA such as HETE species (5-HETE; 8-HETE, etc.)
concentration in plasma (pg/µl plasma)
Full Information
NCT ID
NCT01856179
First Posted
November 29, 2011
Last Updated
May 14, 2013
Sponsor
University of Jena
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01856179
Brief Title
Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans
Official Title
Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of SDA-rich Echium Oil in Humans Depending on Age, Gender and Physiological Stage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
N-3 PUFA are important for human health and nutrition. Due to the increasing world population, overfishing of the seas and generally low amounts of n-3 PUFA in major oil crops, there is a demand for new sources of n-3 PUFA.
One approach involves searching for potential vegetable sources of n-3 PUFA; especially those rich in ALA and SDA. The conversion of ALA to SDA in humans depends on the rate-limiting ∆6-desaturation. Plant-derived SDA is therefore a promising precursor regarding endogenous synthesis of n-3 LC-PUFA in humans. The enrichment of n-3 LC-PUFA in human lipids during the supplementation of ALA- and SDA-rich Echium oil will be compared with SDA-rich soybean oil.
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. 20 g Echium oil ( group 1 and 2: mean BMI < 25, with mean age: 25 or 55 years; group 3: mean age 55 and BMI > 25). One group (n=20) will receive SDA soybean oil ( dose with comparable amount of SDA; BMI < 25; mean age 25 and 55). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia, Overweight
Keywords
Conversion of ALA and SDA, Metabolism of n-3 fatty acids
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Echium oil young
Arm Type
Experimental
Arm Description
BMI<25,
age 20-30
Arm Title
Echium oil older
Arm Type
Experimental
Arm Description
age 40-70 BMI <25
Arm Title
Echium oil older, overweight
Arm Type
Experimental
Arm Description
age 40-70 BMI >25
Intervention Type
Dietary Supplement
Intervention Name(s)
Echium oil
Intervention Description
Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)
Primary Outcome Measure Information:
Title
eicosapentaenic acid
Description
eicosapentaenic acid in lipids of plasma, erythrocytes and peripheral mononuclear cells (% of total identified fatty acid methyl esters)
Time Frame
after 0,7, 56 days
Secondary Outcome Measure Information:
Title
Lipid mediators derived from AA, EPA and DGLA such as HETE species (5-HETE; 8-HETE, etc.)
Description
concentration in plasma (pg/µl plasma)
Time Frame
0 and 56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy subjects
Exclusion Criteria:
cholesterol lowering drugs
chronic diseases
pregnancy, lactation
intake of nutritional supplements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Kuhnt, Dr. rer. nat
Organizational Affiliation
University of Jena, Insitute of Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich Schiller University of Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26892399
Citation
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.
Results Reference
derived
PubMed Identifier
24553695
Citation
Kuhnt 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.
Results Reference
derived
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Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans
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