Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypercholesterolemia, Overweight

Intervention / Treatment
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* Dietary Supplement: Echium oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy subjects Exclusion Criteria: cholesterol lowering drugs chronic diseases pregnancy, lactation intake of nutritional supplements

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echium oil young<br>BMI<25, age 20-30 | Dietary Supplement: Echium oil<br>* Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)<br>|
| Experimental: Echium oil older<br>age 40-70 BMI <25 | Dietary Supplement: Echium oil<br>* Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)<br>|
| Experimental: Echium oil older, overweight<br>age 40-70 BMI >25 | Dietary Supplement: Echium oil<br>* Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eicosapentaenic acid | eicosapentaenic acid in lipids of plasma, erythrocytes and peripheral mononuclear cells (% of total identified fatty acid methyl esters) | after 0,7, 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid mediators derived from AA, EPA and DGLA such as HETE species (5-HETE; 8-HETE, etc.) | concentration in plasma (pg/µl plasma) | 0 and 56 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Conversion of ALA and SDA, Metabolism of n-3 fatty acids