The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
1 other identifier
interventional
79
1 country
1
Brief Summary
The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 11, 2013
CompletedFirst Posted
Study publicly available on registry
January 15, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedDecember 3, 2014
December 1, 2014
1.7 years
January 11, 2013
December 2, 2014
Conditions
Outcome Measures
Primary Outcomes (7)
Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test
change in glucose metabolism
Baseline and 12 weeks
Serum lipid profile
Change in serum lipid profile
Baseline and at 12 weeks
Blood pressure
Change in blood pressure
Baseline and 12 weeks
Serum inflammatory markers
Change in serum inflammatory markers
baseline and 12 weeks
Plasma and adipose tissue lipidomic profile
Change in plasma and adipose tissue lipidomic profile
Baseline and 12 weeks
Plasma and urine metabonomics
Change in plasma and urine metabonomics
Baseline and 12 weeks
Gene expression in adipose tissue and peripheral blood mononuclear cells
Change in gene expression in adipose tissue and peripheral blood mononuclear cells
Baseline and 12 weeks
Secondary Outcomes (1)
Reverse cholesterol transport
Baseline and 12 weeks
Study Arms (4)
Fatty fish
EXPERIMENTALFour fatty fish meals per week
Lean Fish
EXPERIMENTALFour lean fish meals per week
Alpha-linolenic acid
EXPERIMENTAL10 g of alpha-linolenic acid daily from camelina sativa oil
Control diet
EXPERIMENTALLimited fish and alpha-linolenic acid intake
Interventions
Eligibility Criteria
You may qualify if:
- age 40-70 years
- BMI 25-32 kg/m2
- fasting plasma glucose 5.6-7.0 mmol/l
- h plasma glucose in oral glucose tolerance test \<=11 mmol/l
- fasting serum total cholesterol \<=7 mmol/l
- fasting serum LDL cholesterol \<=5 mmol/l
- fasting serum triglycerides \<=4 mmol/l
You may not qualify if:
- any chronic disease or condition that hamper the ability to follow dietary intervention
- chronic liver, thyroid or kidney disease
- alcohol abuse
- diabetes
- recent weight loss
- recent myocardial infarction
- corticosteroid therapy
- psychiatric disorders which need drug treatment
- cancer under treatment
- fish allergy or other extensive food allergies
- exceptional diets (like Atkin's or vegan diet)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Eastern Finlandlead
- Kuopio University Hospitalcollaborator
- VTT Technical Research Centre, Finlandcollaborator
Study Sites (1)
University of Eastern Finland
Kuopio, Finland
Related Publications (4)
Meuronen T, Lankinen MA, Fauland A, Shimizu BI, de Mello VD, Laaksonen DE, Wheelock CE, Erkkila AT, Schwab US. Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial. Prostaglandins Leukot Essent Fatty Acids. 2020 Aug;159:102143. doi: 10.1016/j.plefa.2020.102143. Epub 2020 May 30.
PMID: 32512364DERIVEDManninen S, Lankinen M, Erkkila A, Nguyen SD, Ruuth M, de Mello V, Oorni K, Schwab U. The effect of intakes of fish and Camelina sativa oil on atherogenic and anti-atherogenic functions of LDL and HDL particles: A randomized controlled trial. Atherosclerosis. 2019 Feb;281:56-61. doi: 10.1016/j.atherosclerosis.2018.12.017. Epub 2018 Dec 23.
PMID: 30658192DERIVEDManninen S, Lankinen M, de Mello V, Agren J, Laaksonen D, Schwab U, Erkkila A. The effect of camelina sativa oil and fish intakes on fatty acid compositions of blood lipid fractions. Nutr Metab Cardiovasc Dis. 2019 Jan;29(1):51-61. doi: 10.1016/j.numecd.2018.10.002. Epub 2018 Oct 11.
PMID: 30454883DERIVEDManninen SM, Lankinen MA, de Mello VD, Laaksonen DE, Schwab US, Erkkila AT. Intake of Fatty Fish Alters the Size and the Concentration of Lipid Components of HDL Particles and Camelina Sativa Oil Decreases IDL Particle Concentration in Subjects with Impaired Glucose Metabolism. Mol Nutr Food Res. 2018 May;62(10):e1701042. doi: 10.1002/mnfr.201701042.
PMID: 29645359DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arja Erkkilä, Adjunct Prof
University of Eastern Finland
- PRINCIPAL INVESTIGATOR
Ursula Schwab, Adjunct Prof
University of Eastern Finland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2013
First Posted
January 15, 2013
Study Start
October 1, 2012
Primary Completion
June 1, 2014
Last Updated
December 3, 2014
Record last verified: 2014-12