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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01768429
Other study ID # ALFAKALA
Secondary ID
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. completion date
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


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
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