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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01856179
First received: November 29, 2011
Last updated: May 14, 2013
Last verified: May 2013

November 29, 2011
May 14, 2013
March 2011
August 2011   (final data collection date for primary outcome measure)
eicosapentaenic acid [ Time Frame: after 0,7, 56 days ] [ Designated as safety issue: No ]
eicosapentaenic acid in lipids of plasma, erythrocytes and peripheral mononuclear cells (% of total identified fatty acid methyl esters)
Same as current
Complete list of historical versions of study NCT01856179 on ClinicalTrials.gov Archive Site
Lipid mediators derived from AA, EPA and DGLA such as HETE species (5-HETE; 8-HETE, etc.) [ Time Frame: 0 and 56 days ] [ Designated as safety issue: No ]
concentration in plasma (pg/µl plasma)
Same as current
Not Provided
Not Provided
 
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

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).

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.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hypercholesterolemia
  • Overweight
Dietary Supplement: Echium oil
Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)
  • Experimental: Echium oil young

    BMI<25,

    age 20-30

    Intervention: Dietary Supplement: Echium oil
  • Experimental: Echium oil older
    age 40-70 BMI <25
    Intervention: Dietary Supplement: Echium oil
  • Experimental: Echium oil older, overweight
    age 40-70 BMI >25
    Intervention: Dietary Supplement: Echium oil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
April 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • cholesterol lowering drugs
  • chronic diseases
  • pregnancy, lactation
  • intake of nutritional supplements
Both
20 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01856179
LSEP H42-KK
Yes
Gerhard Jahreis, University of Jena
University of Jena
German Research Foundation
Principal Investigator: Katrin Kuhnt, Dr. rer. nat University of Jena, Insitute of Nutrition
University of Jena
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP