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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Overweight, Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: n-3 PUFA free olive oil
* Dietary Supplement: linseed 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: linseed oil; young<br>ALA rich linseed oil to younger subjects (18-35 years) | Dietary Supplement: linseed oil<br> <br> |
| Experimental: linseed oil; older<br>ALA rich linseed oil to older, normalweight subjects (BMI <25, age 49-69 years) | Dietary Supplement: linseed oil<br> <br> |
| Experimental: linseed oil older, overweight<br>ALA-rich linseed oil to older, normalweight subjects (BMI >25, age 49-69 years) | Dietary Supplement: linseed oil<br> <br> |
| Experimental: olive oil<br>n3-PUFA free control oil to normalweight subjects (BMI <25) | Dietary Supplement: n-3 PUFA free olive oil<br>* negative control<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eicosanoid concentration in 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