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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01768429
Enrollment
79
Registered
2013-01-15
Start date
2012-10-31
Completion date
Unknown
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperglycemia

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.

Interventions

BEHAVIORALFatty fish
BEHAVIORALLean Fish
BEHAVIORALControl

Sponsors

Kuopio University Hospital
CollaboratorOTHER
VTT Technical Research Centre, Finland
CollaboratorOTHER
University of Eastern Finland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Gene expression in adipose tissue and peripheral blood mononuclear cellsBaseline and 12 weeksChange in gene expression in adipose tissue and peripheral blood mononuclear cells
Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance testBaseline and 12 weekschange in glucose metabolism
Serum lipid profileBaseline and at 12 weeksChange in serum lipid profile
Blood pressureBaseline and 12 weeksChange in blood pressure
Serum inflammatory markersbaseline and 12 weeksChange in serum inflammatory markers
Plasma and adipose tissue lipidomic profileBaseline and 12 weeksChange in plasma and adipose tissue lipidomic profile
Plasma and urine metabonomicsBaseline and 12 weeksChange in plasma and urine metabonomics

Secondary

MeasureTime frameDescription
Reverse cholesterol transportBaseline and 12 weeksChange in reverse cholesterol transport

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026