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

NCT ID: NCT01856179

Last Updated: 2013-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-04-30

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.

Conditions

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Hypercholesterolemia Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Echium oil young

BMI\<25,

age 20-30

Group Type EXPERIMENTAL

Echium oil

Intervention Type DIETARY_SUPPLEMENT

Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)

Echium oil older

age 40-70 BMI \<25

Group Type EXPERIMENTAL

Echium oil

Intervention Type DIETARY_SUPPLEMENT

Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)

Echium oil older, overweight

age 40-70 BMI \>25

Group Type EXPERIMENTAL

Echium oil

Intervention Type DIETARY_SUPPLEMENT

Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)

Interventions

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Echium oil

Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* healthy subjects

Exclusion Criteria

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

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Jahreis

Prof. Dr. habil.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katrin Kuhnt, Dr. rer. nat

Role: PRINCIPAL_INVESTIGATOR

University of Jena, Insitute of Nutrition

Locations

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Friedrich Schiller University of Jena

Jena, Thuringia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 26892399 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24553695 (View on PubMed)

Other Identifiers

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LSEP H42-KK

Identifier Type: -

Identifier Source: org_study_id

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