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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01317290
First Posted: March 17, 2011
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
  Purpose
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).

Condition Intervention Phase
Overweight Hypercholesterolemia Dietary Supplement: n-3 PUFA free olive oil Dietary Supplement: linseed oil Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of ALA-rich Oil in Humans Depending on Age, Gender and Physiological Stage.

Resource links provided by NLM:


Further study details as provided by Gerhard Jahreis, University of Jena:

Primary Outcome Measures:
  • n-3 LC-PUFA in human lipids (EPA) [ Time Frame: 0,7,56 days ]
    EPA (% of total identified fatty acid methyl esters)


Secondary Outcome Measures:
  • eicosanoid concentration in plasma [ Time Frame: 0 and 56 days ]

Enrollment: 78
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: linseed oil; young
ALA rich linseed oil to younger subjects (18-35 years)
Dietary Supplement: linseed oil
Experimental: linseed oil; older
ALA rich linseed oil to older, normalweight subjects (BMI <25, age 49-69 years)
Dietary Supplement: linseed oil
Experimental: linseed oil older, overweight
ALA-rich linseed oil to older, normalweight subjects (BMI >25, age 49-69 years)
Dietary Supplement: linseed oil
Experimental: olive oil
n3-PUFA free control oil to normalweight subjects (BMI <25)
Dietary Supplement: n-3 PUFA free olive oil
negative control

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317290


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

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: NCT01317290     History of Changes
Other Study ID Numbers: H50-11-KK
First Submitted: March 16, 2011
First Posted: March 17, 2011
Last Update Posted: November 13, 2013
Last Verified: November 2013

Keywords provided by Gerhard Jahreis, University of Jena:
Conversion of ALA

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


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