Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans (ALA_KK)
Primary Purpose
Overweight, Hypercholesterolemia
Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
n-3 PUFA free olive oil
linseed oil
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Conversion of ALA
Eligibility Criteria
Inclusion Criteria:
- healthy subjects
Exclusion Criteria:
- cholesterol lowering drugs
- chronic diseases
- pregnancy, lactation
- intake of nutritional supplements
Sites / Locations
- Friedrich Schiller University of Jena
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
linseed oil; young
linseed oil; older
linseed oil older, overweight
olive oil
Arm Description
ALA rich linseed oil to younger subjects (18-35 years)
ALA rich linseed oil to older, normalweight subjects (BMI <25, age 49-69 years)
ALA-rich linseed oil to older, normalweight subjects (BMI >25, age 49-69 years)
n3-PUFA free control oil to normalweight subjects (BMI <25)
Outcomes
Primary Outcome Measures
n-3 LC-PUFA in human lipids (EPA)
EPA (% of total identified fatty acid methyl esters)
Secondary Outcome Measures
eicosanoid concentration in plasma
Full Information
NCT ID
NCT01317290
First Posted
March 16, 2011
Last Updated
November 12, 2013
Sponsor
University of Jena
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01317290
Brief Title
Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans
Acronym
ALA_KK
Official Title
Accumulation of n-3 Long-chain (LC)-PUFA by Supplementation of ALA-rich Oil in Humans Depending on Age, Gender and Physiological Stage.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jena
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Hypercholesterolemia
Keywords
Conversion of ALA
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
linseed oil; young
Arm Type
Experimental
Arm Description
ALA rich linseed oil to younger subjects (18-35 years)
Arm Title
linseed oil; older
Arm Type
Experimental
Arm Description
ALA rich linseed oil to older, normalweight subjects (BMI <25, age 49-69 years)
Arm Title
linseed oil older, overweight
Arm Type
Experimental
Arm Description
ALA-rich linseed oil to older, normalweight subjects (BMI >25, age 49-69 years)
Arm Title
olive oil
Arm Type
Experimental
Arm Description
n3-PUFA free control oil to normalweight subjects (BMI <25)
Intervention Type
Dietary Supplement
Intervention Name(s)
n-3 PUFA free olive oil
Intervention Description
negative control
Intervention Type
Dietary Supplement
Intervention Name(s)
linseed oil
Primary Outcome Measure Information:
Title
n-3 LC-PUFA in human lipids (EPA)
Description
EPA (% of total identified fatty acid methyl esters)
Time Frame
0,7,56 days
Secondary Outcome Measure Information:
Title
eicosanoid concentration in plasma
Time Frame
0 and 56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy subjects
Exclusion Criteria:
cholesterol lowering drugs
chronic diseases
pregnancy, lactation
intake of nutritional supplements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrin Kuhnt, Dr. rer. nat
Organizational Affiliation
University of Jena, Insitute of Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich Schiller University of Jena
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26892399
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.
Results Reference
derived
PubMed Identifier
24229084
Citation
Grindel A, Staps F, Kuhnt K. Cheek cell fatty acids reflect n-3 PUFA in blood fractions during linseed oil supplementation: a controlled human intervention study. Lipids Health Dis. 2013 Nov 14;12:173. doi: 10.1186/1476-511X-12-173.
Results Reference
derived
Learn more about this trial
Supplementation of Alpha-linolenic Acid (ALA)-Rich Oil in Humans
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