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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by University of Jena

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014