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Completed

NCT Number: NCT01856179

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

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).

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Friedrich Schiller University of Jena

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subjects

Exclusion criteria

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

Treatment and study plan

Echium oil

Dietary Supplement

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • German Research Foundation

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
May 17, 2013
Registry last updated
May 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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