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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.

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01317290
Acronym
ALA_KK
Enrollment
78
Registered
2011-03-17
Start date
2012-02-29
Completion date
2013-05-31
Last updated
2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Hypercholesterolemia

Keywords

Conversion of ALA

Brief summary

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).

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.

Interventions

DIETARY_SUPPLEMENTn-3 PUFA free olive oil

negative control

DIETARY_SUPPLEMENTlinseed oil

Sponsors

German Research Foundation
CollaboratorOTHER
University of Jena
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy subjects

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
n-3 LC-PUFA in human lipids (EPA)0,7,56 daysEPA (% of total identified fatty acid methyl esters)

Secondary

MeasureTime frame
eicosanoid concentration in plasma0 and 56 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026