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

Early Phase 1

Completed

• Conditions: Overweight; Hypercholesterolemia

• Registration Number: NCT01856179
• Lead Sponsor: University of Jena

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-08
• Study First Submitted: 2011-11-29
• Study Completion: 2012-04
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-14
• Last Update Submitted: 2013-05-14
• Study First Posted: 2013-05-17
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• healthy subjects

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
eicosapentaenic acid	after 0,7, 56 days	eicosapentaenic acid in lipids of plasma, erythrocytes and peripheral mononuclear cells (% of total identified fatty acid methyl esters)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Friedrich Schiller University of Jena; 🇩🇪 Jena, Thuringia, Germany