Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans (ALA_KK)

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01317290
First received: March 16, 2011
Last updated: November 12, 2013
Last verified: November 2013

March 16, 2011
November 12, 2013
February 2012
September 2012   (final data collection date for primary outcome measure)
n-3 LC-PUFA in human lipids (EPA) [ Time Frame: 0,7,56 days ] [ Designated as safety issue: Yes ]
EPA (% of total identified fatty acid methyl esters)
increase of n-3 LC-PUFA in human lipids [ Time Frame: 0,7,56 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01317290 on ClinicalTrials.gov Archive Site
eicosanoid concentration in plasma [ Time Frame: 0 and 56 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans
Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of ALA-rich Oil in Humans Depending on Age, Gender and Physiological Stage.

The objective of this study is to investigate the accumulation of n-3 LC-PUFA (EPA, DPA and DHA) in human lipids by oral supplementation of ALA-rich linseed oil. 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. Unfortunately, the land-based n-3 ALA is a limited precursor for the formation of n-3 LC-PUFA. The conversion of ALA depends on the rate-limiting ∆6-desaturation.

The first objective of this study is to investigate differences of the accumulation of n-3 LC-PUFA (EPA, DPA and DHA) in human lipids during supplementation of ALA-rich linseed oil dependent on age, gender and physiological conditions (overweight, increased serum total cholesterol). One study group will receive fish oil with mainly EPA as positive control.

The second objective is to compare the n-3 LC-PUFA enrichment during the linseed oil supplementation (study LSEP H50-KK) with the n-3 LC-PUFA enrichment during the further Echium oil supplementation (study LSEP H42-KK). The second study will be the control for the first study.

Therefore, it is planned to recruit the same subjects for the linseed oil supplementation.

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. 15 g linseed oil (mean age: 25 and 55 years; mean BMI < 25; and mean age 55 and BMI > 25). One group (n=20) will receive n-3PUFA free olive oil (mean age 25 and 55, BMI < 25). 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.

Altogether, the fatty acid distribution after Echium oil and linseed oil supplementation from similar subjects can be statistically analysed.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Overweight
  • Hypercholesterolemia
  • Dietary Supplement: n-3 PUFA free olive oil
    negative control
  • Dietary Supplement: linseed oil
  • Experimental: linseed oil; young
    ALA rich linseed oil to younger subjects (18-35 years)
    Intervention: Dietary Supplement: linseed oil
  • Experimental: linseed oil; older
    ALA rich linseed oil to older, normalweight subjects (BMI <25, age 49-69 years)
    Intervention: Dietary Supplement: linseed oil
  • Experimental: linseed oil older, overweight
    ALA-rich linseed oil to older, normalweight subjects (BMI >25, age 49-69 years)
    Intervention: Dietary Supplement: linseed oil
  • Experimental: olive oil
    n3-PUFA free control oil to normalweight subjects (BMI <25)
    Intervention: Dietary Supplement: n-3 PUFA free olive oil
Grindel A, Staps F, Kuhnt K. Cheek cell fatty acids reflect n-3 PUFA in blood fractions during linseed oil supplementation: a controlled human intervention study. Lipids Health Dis. 2013 Nov 14;12:173. doi: 10.1186/1476-511X-12-173.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
May 2013
September 2012   (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
 
NCT01317290
H50-11-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
November 2013

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