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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia
• Intervention / Treatment: Behavioral: Control; Behavioral: Fatty fish; Behavioral: Lean Fish; Behavioral: Alpha-linolenic acid

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland
    • University of Eastern Finland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fatty fish; Four fatty fish meals per week	Behavioral: Fatty fish
Experimental: Lean Fish; Four lean fish meals per week	Behavioral: Lean Fish
Experimental: Alpha-linolenic acid; 10 g of alpha-linolenic acid daily from camelina sativa oil	Behavioral: Alpha-linolenic acid
Experimental: Control diet; Limited fish and alpha-linolenic acid intake	Behavioral: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reverse cholesterol transport	Change in reverse cholesterol transport	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Collaborators: Kuopio University Hospital; VTT Technical Research Centre, Finland
• Investigators: Principal Investigator: Arja Erkkilä, Adjunct Prof, University of Eastern Finland; Principal Investigator: Ursula Schwab, Adjunct Prof, University of Eastern Finland

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 11, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (Estimate): January 15, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia
• Other Study ID Numbers: ALFAKALA