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

Not Applicable

Completed

• Conditions: Hyperglycemia
• Interventions: Behavioral: Alpha-linolenic acid; Behavioral: Lean Fish; Behavioral: Fatty fish; Behavioral: Control

• Registration Number: NCT01768429
• Lead Sponsor: University of Eastern Finland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-15
• Primary Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alpha-linolenic acid	Alpha-linolenic acid	10 g of alpha-linolenic acid daily from camelina sativa oil
Lean Fish	Lean Fish	Four lean fish meals per week
Fatty fish	Fatty fish	Four fatty fish meals per week
Control diet	Control	Limited fish and alpha-linolenic acid intake

Primary Outcome Measures

Name	Time	Method
Blood pressure	Baseline and 12 weeks	Change in blood pressure
Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test	Baseline and 12 weeks	change in glucose metabolism
Serum lipid profile	Baseline and at 12 weeks	Change in serum lipid profile
Plasma and urine metabonomics	Baseline and 12 weeks	Change in plasma and urine metabonomics
Serum inflammatory markers	baseline and 12 weeks	Change in serum inflammatory markers
Plasma and adipose tissue lipidomic profile	Baseline and 12 weeks	Change in plasma and adipose tissue lipidomic profile
Gene expression in adipose tissue and peripheral blood mononuclear cells	Baseline and 12 weeks	Change in gene expression in adipose tissue and peripheral blood mononuclear cells

Secondary Outcome Measures

Name	Time	Method
Reverse cholesterol transport	Baseline and 12 weeks	Change in reverse cholesterol transport

Trial Locations

Locations (1)

University of Eastern Finland; 🇫🇮 Kuopio, Finland