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

November 12, 2013 updated by: Gerhard Jahreis, University of Jena

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thuringia
      • Jena, Thuringia, Germany, 07743
        • Friedrich Schiller University of Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy subjects

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
eicosanoid concentration in plasma
Time Frame: 0 and 56 days
0 and 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Katrin Kuhnt, Dr. rer. nat, University of Jena, Insitute of Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 16, 2011

First Posted (Estimate)

March 17, 2011

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 12, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H50-11-KK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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