Clinical trial NCT01317290: Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Overweight
Hypercholesterolemia
Keywords: Conversion of ALA
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2011-03-17
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

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

Primary outcomes:
measure: n-3 LC-PUFA in human lipids (EPA)
timeFrame: 0,7,56 days
Secondary outcomes:
measure: eicosanoid concentration in plasma
timeFrame: 0 and 56 days
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University of Jena
state: Thuringia
Study officials:
affiliation: University of Jena, Insitute of Nutrition
name: Katrin Kuhnt, Dr. rer. nat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuhnt K, Weiss S, Kiehntopf M, Jahreis G. Consumption of echium oil increases EPA and DPA in blood fractions more efficiently compared to linseed oil in humans. Lipids Health Dis. 2016 Feb 18;15:32. doi: 10.1186/s12944-016-0199-2.
citation: Grindel A, Staps F, Kuhnt K. Cheek cell fatty acids reflect n-3 PUFA in blood fractions during linseed oil supplementation: a controlled human intervention study. Lipids Health Dis. 2013 Nov 14;12:173. doi: 10.1186/1476-511X-12-173.