Clinical trial NCT01768429: The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
Official title: The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
Collaborators: name: Kuopio University Hospital
name: VTT Technical Research Centre, Finland
First posted: 2013-01-15
Enrollment: 79
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test
timeFrame: Baseline and 12 weeks
measure: Serum lipid profile
timeFrame: Baseline and at 12 weeks
measure: Blood pressure
timeFrame: Baseline and 12 weeks
measure: Serum inflammatory markers
timeFrame: baseline and 12 weeks
measure: Plasma and adipose tissue lipidomic profile
timeFrame: Baseline and 12 weeks
measure: Plasma and urine metabonomics
timeFrame: Baseline and 12 weeks
measure: Gene expression in adipose tissue and peripheral blood mononuclear cells
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Reverse cholesterol transport
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: University of Eastern Finland
name: Arja Erkkilä, Adjunct Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Eastern Finland
name: Ursula Schwab, Adjunct Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.