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Completed

NCT Number: NCT01317290

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

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).

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Friedrich Schiller University of Jena

Jena, Thuringia, 07743, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy subjects

Exclusion criteria

  • cholesterol lowering drugs
  • chronic diseases
  • pregnancy, lactation
  • intake of nutritional supplements

Treatment and study plan

n-3 PUFA free olive oil

Dietary Supplement

negative control

linseed oil

Dietary Supplement

Primary outcomes

  1. n-3 LC-PUFA in human lipids (EPA)

    Time frame: 0,7,56 days

    EPA (% of total identified fatty acid methyl esters)

Secondary outcomes

  1. eicosanoid concentration in plasma

    Time frame: 0 and 56 days

Sponsors and collaborators

Lead sponsor

University of Jena

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of ALA-rich Oil in Humans Depending on Age, Gender and Physiological Stage.

Acronym: ALA_KK

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 17, 2011
Registry last updated
Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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