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

Hyperglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768429
• Other study ID #: ALFAKALA
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: December 2, 2014
• Start date: October 2012

Study information

• Verified date: December 2014
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics CommitteeFinland: National Advisory Board on Health Care Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyperglycemia

Intervention

Behavioral:
• Fatty fish

• Lean Fish

• Alpha-linolenic acid

• Control

Locations

Country	Name	City	State
Finland	University of Eastern Finland	Kuopio

Sponsors (3)

Lead Sponsor	Collaborator
University of Eastern Finland	Kuopio University Hospital, VTT Technical Research Centre, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test	change in glucose metabolism	Baseline and 12 weeks	No
Primary	Serum lipid profile	Change in serum lipid profile	Baseline and at 12 weeks	No
Primary	Blood pressure	Change in blood pressure	Baseline and 12 weeks	No
Primary	Serum inflammatory markers	Change in serum inflammatory markers	baseline and 12 weeks	No
Primary	Plasma and adipose tissue lipidomic profile	Change in plasma and adipose tissue lipidomic profile	Baseline and 12 weeks	No
Primary	Plasma and urine metabonomics	Change in plasma and urine metabonomics	Baseline and 12 weeks	No
Primary	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	No
Secondary	Reverse cholesterol transport	Change in reverse cholesterol transport	Baseline and 12 weeks	No