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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: May 14, 2013
Last verified: May 2013
History of Changes
  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: EPA-rich fish oil
Dietary Supplement: linseed 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 ALA-rich Oil in Humans Depending on Age, Gender and Physiological Stage.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • eicosanoid concentration in plasma [ Time Frame: 0 and 56 days ] [ Designated as safety issue: Yes ]

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: EPA-rich fish oil

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 EPA-rich fish 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 the same subjects can be statistically analyzed as a cross-over study.

  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: 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

No publications provided

Responsible Party: Gerhard Jahreis, Prof. Dr. habil., University of Jena
ClinicalTrials.gov Identifier: NCT01317290     History of Changes
Other Study ID Numbers: H50-11-KK
Study First Received: March 16, 2011
Last Updated: May 14, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
Conversion of ALA

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

ClinicalTrials.gov processed this record on June 18, 2013