Clinical trial NCT01856179: Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans
Official title: Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of SDA-rich Echium Oil in Humans Depending on Age, Gender and Physiological Stage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hypercholesterolemia
Overweight
Keywords: Conversion of ALA and SDA
Metabolism of n-3 fatty acids
Lead sponsor: University of Jena
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2013-05-17
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 conversion of the precursors ALA and SDA into n-3 LC-PUFA (EPA, DPA and DHA) in humans by oral supplementation of Echium oil in comparison with SDA soybean oil (positive control). 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. Due to the increasing world population, overfishing of the seas and generally low amounts of n-3 PUFA in major oil crops, there is a demand for new sources of n-3 PUFA.

One approach involves searching for potential vegetable sources of n-3 PUFA; especially those rich in ALA and SDA. The conversion of ALA to SDA in humans depends on the rate-limiting ∆6-desaturation. Plant-derived SDA is therefore a promising precursor regarding endogenous synthesis of n-3 LC-PUFA in humans. The enrichment of n-3 LC-PUFA in human lipids during the supplementation of ALA- and SDA-rich Echium oil will be compared with SDA-rich soybean oil.

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. 20 g Echium oil ( group 1 and 2: mean BMI \< 25, with mean age: 25 or 55 years; group 3: mean age 55 and BMI \> 25). One group (n=20) will receive SDA soybean oil ( dose with comparable amount of SDA; BMI \< 25; mean age 25 and 55). 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.

Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

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

Primary outcomes:
measure: eicosapentaenic acid
timeFrame: after 0,7, 56 days
Secondary outcomes:
measure: Lipid mediators derived from AA, EPA and DGLA such as HETE species (5-HETE; 8-HETE, etc.)
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: Kuhnt K, Fuhrmann C, Kohler M, Kiehntopf M, Jahreis G. Dietary echium oil increases long-chain n-3 PUFAs, including docosapentaenoic acid, in blood fractions and alters biochemical markers for cardiovascular disease independently of age, sex, and metabolic syndrome. J Nutr. 2014 Apr;144(4):447-60. doi: 10.3945/jn.113.180802. Epub 2014 Feb 19.