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
  Purpose

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 Intervention Phase
Hypercholesterolemia
Overweight
Dietary Supplement: Echium oil
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Jena:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 78
Study Start Date: March 2011
Study Completion Date: April 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Echium oil young

BMI<25,

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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

  • cholesterol lowering drugs
  • chronic diseases
  • pregnancy, lactation
  • intake of nutritional supplements
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01856179

Locations
Germany
Friedrich Schiller University of Jena
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
German Research Foundation
Investigators
Principal Investigator: Katrin Kuhnt, Dr. rer. nat University of Jena, Insitute of Nutrition
  More Information

No publications provided

Responsible Party: Gerhard Jahreis, Prof. Dr. habil., University of Jena
ClinicalTrials.gov Identifier: NCT01856179     History of Changes
Other Study ID Numbers: LSEP H42-KK
Study First Received: November 29, 2011
Last Updated: May 14, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
Conversion of ALA and SDA
Metabolism of n-3 fatty acids

Additional relevant MeSH terms:
Hypercholesterolemia
Overweight
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014