The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism

NCT ID: NCT01768429

Last Updated: 2014-12-03

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

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Fatty fish

Four fatty fish meals per week

Group Type EXPERIMENTAL

Fatty fish

Intervention Type BEHAVIORAL

Lean Fish

Four lean fish meals per week

Group Type EXPERIMENTAL

Lean Fish

Intervention Type BEHAVIORAL

Alpha-linolenic acid

10 g of alpha-linolenic acid daily from camelina sativa oil

Group Type EXPERIMENTAL

Alpha-linolenic acid

Intervention Type BEHAVIORAL

Control diet

Limited fish and alpha-linolenic acid intake

Group Type EXPERIMENTAL

Control

Intervention Type BEHAVIORAL

Interventions

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Fatty fish

Intervention Type BEHAVIORAL

Lean Fish

Intervention Type BEHAVIORAL

Alpha-linolenic acid

Intervention Type BEHAVIORAL

Control

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* age 40-70 years
* BMI 25-32 kg/m2
* fasting plasma glucose 5.6-7.0 mmol/l
* 2 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

Exclusion Criteria

* 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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kuopio University Hospital

OTHER

Sponsor Role collaborator

VTT Technical Research Centre, Finland

OTHER

Sponsor Role collaborator

University of Eastern Finland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arja Erkkilä, Adjunct Prof

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Ursula Schwab, Adjunct Prof

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

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University of Eastern Finland

Kuopio, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 32512364 (View on PubMed)

Manninen 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.

Reference Type DERIVED
PMID: 30658192 (View on PubMed)

Manninen 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.

Reference Type DERIVED
PMID: 30454883 (View on PubMed)

Manninen 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.

Reference Type DERIVED
PMID: 29645359 (View on PubMed)

Other Identifiers

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ALFAKALA

Identifier Type: -

Identifier Source: org_study_id