The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Blood pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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)
Outcomes
Primary Outcomes
Blood pressure
Time Frame: Baseline and 12 weeks
Change in blood pressure
Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test
Time Frame: Baseline and 12 weeks
change in glucose metabolism
Serum lipid profile
Time Frame: Baseline and at 12 weeks
Change in serum lipid profile
Plasma and urine metabonomics
Time Frame: Baseline and 12 weeks
Change in plasma and urine metabonomics
Serum inflammatory markers
Time Frame: baseline and 12 weeks
Change in serum inflammatory markers
Plasma and adipose tissue lipidomic profile
Time Frame: Baseline and 12 weeks
Change in plasma and adipose tissue lipidomic profile
Gene expression in adipose tissue and peripheral blood mononuclear cells
Time Frame: Baseline and 12 weeks
Change in gene expression in adipose tissue and peripheral blood mononuclear cells
Secondary Outcomes
- Reverse cholesterol transport(Baseline and 12 weeks)