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Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01856179
Recruitment Status : Completed
First Posted : May 17, 2013
Last Update Posted : May 17, 2013
German Research Foundation
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena

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).

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Overweight Dietary Supplement: Echium oil Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : March 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : April 2012

Arm Intervention/treatment
Experimental: Echium oil young


age 20-30

Dietary Supplement: Echium oil
Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)

Experimental: Echium oil older
age 40-70 BMI <25
Dietary Supplement: Echium oil
Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)

Experimental: Echium oil older, overweight
age 40-70 BMI >25
Dietary Supplement: Echium oil
Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)

Primary Outcome Measures :
  1. eicosapentaenic acid [ Time Frame: after 0,7, 56 days ]
    eicosapentaenic acid in lipids of plasma, erythrocytes and peripheral mononuclear cells (% of total identified fatty acid methyl esters)

Secondary Outcome Measures :
  1. Lipid mediators derived from AA, EPA and DGLA such as HETE species (5-HETE; 8-HETE, etc.) [ Time Frame: 0 and 56 days ]
    concentration in plasma (pg/µl plasma)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • cholesterol lowering drugs
  • chronic diseases
  • pregnancy, lactation
  • intake of nutritional supplements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01856179

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Friedrich Schiller University of Jena
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
German Research Foundation
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Principal Investigator: Katrin Kuhnt, Dr. rer. nat University of Jena, Insitute of Nutrition
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gerhard Jahreis, Prof. Dr. habil., University of Jena Identifier: NCT01856179    
Other Study ID Numbers: LSEP H42-KK
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: May 2013
Keywords provided by Gerhard Jahreis, University of Jena:
Conversion of ALA and SDA
Metabolism of n-3 fatty acids
Additional relevant MeSH terms:
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Body Weight
Lipid Metabolism Disorders
Metabolic Diseases