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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Eastern Finland
Sponsor:
Collaborators:
Kuopio University Hospital
VTT Technical Research Centre, Finland
Information provided by (Responsible Party):
University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT01768429
First received: January 11, 2013
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Hyperglycemia
Behavioral: Fatty fish
Behavioral: Lean Fish
Behavioral: Alpha-linolenic acid
Behavioral: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    change in glucose metabolism

  • Serum lipid profile [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
    Change in serum lipid profile

  • Blood pressure [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in blood pressure

  • Serum inflammatory markers [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in serum inflammatory markers

  • Plasma and adipose tissue lipidomic profile [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in plasma and adipose tissue lipidomic profile

  • Plasma and urine metabonomics [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in plasma and urine metabonomics

  • Gene expression in adipose tissue and peripheral blood mononuclear cells [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in gene expression in adipose tissue and peripheral blood mononuclear cells


Secondary Outcome Measures:
  • Reverse cholesterol transport [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    Change in reverse cholesterol transport


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fatty fish
Four fatty fish meals per week
Behavioral: Fatty fish
Experimental: Lean Fish
Four lean fish meals per week
Behavioral: Lean Fish
Experimental: Alpha-linolenic acid
10 g of alpha-linolenic acid daily from camelina sativa oil
Behavioral: Alpha-linolenic acid
Experimental: Control diet
Limited fish and alpha-linolenic acid intake
Behavioral: Control

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01768429

Contacts
Contact: Arja Erkkilä arja.erkkila@uef.fi

Locations
Finland
University of Eastern Finland Recruiting
Kuopio, Finland
Contact: Arja Erkkilä       arja.erkkila@uef.fi   
Sponsors and Collaborators
University of Eastern Finland
Kuopio University Hospital
VTT Technical Research Centre, Finland
Investigators
Principal Investigator: Arja Erkkilä, Adjunct Prof University of Eastern Finland
Principal Investigator: Ursula Schwab, Adjunct Prof University of Eastern Finland
  More Information

No publications provided

Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT01768429     History of Changes
Other Study ID Numbers: ALFAKALA
Study First Received: January 11, 2013
Last Updated: December 20, 2013
Health Authority: Finland: Ethics Committee
Finland: National Advisory Board on Health Care Ethics

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014