Gene - Diet Interactions

NCT01274091 | Completed

• 1 other identifier: 28//2010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Interactions between genes and environment, i.e. our inherited responses to environmental changes, may be crucial in the development of the common diseases. The investigators were the first to identify PPARG gene as risk gene for type 2 diabetes. The role of the Pro12Ala polymorphism in diabetes risk has also been verified in meta-analysis. However, this effect on seems to depend on intervention and age. In this study the effects of diets high with saturated fatty acids (SAFA) and polyunsaturated fatty acids (PUFA) are compared in subjects carrying either Pro12Pro or Ala12Ala genotype of the PPARG gene. Aim of the study: To test if subjects with Pro12Pro and Ala12Ala genotypes respond differentially to a diet supplemented with high saturated (SAFA) or polyunsaturated fat (PUFA). Hypotheses:

1. 1.Specific: Subjects with the Ala12Ala genotype will be more sensitive to dietary modification, and therefore respond more favorably to PUFA diet
2. 2.More general: Dietary instructions individually tailored according to the genotype would allow better treatment of obesity and diabetes

Conditions

Insulin Sensitivity

Keywords

Gene-diet interaction; PPARgamma gene; Pro12Ala; Fatty acids; Dietary modification; Insulin sensitivity; Glucose metabolism

Outcome Measures

Primary Outcomes (4)

• insulin sensitivity

  insulin sensitivity measured by oral glucose tolerance test at the beginning of the first, randomised diet

  week 0

• insulin sensitivity

  insulin sensitivty measured by oral glucose tolerance test after the first diet

  week 8

• insulin sensitivity

  Insulin sensitivity measured by oral glucose tolerance test in the beginning of the second, randomised diet

  week 10

• insulin sensitivity

  insulin sensitivity measured by oral glucose tolerance test after the second diet

  week 18

Secondary Outcomes (12)

• peripheral blood mononuclear cell gene expression

  week 8

• peripheral blood mononuclear cell gene expression

  week 18

• serum lipids

  week 8

• serum lipids

  week 18

• inflammation

  week 8

Study Arms (2)

P/S-ratio 1.0

EXPERIMENTAL

Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: polyunsaturated fatty acid diet (PUFA) will have P/S ratio 1.0.

Other: PUFA-diet

P/S-ration 0.3

EXPERIMENTAL

Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates:. Saturated fatty acid diet (SAFA) will polyunsaturated/saturated (P/S) ratio of 0.3.

Other: SAFA-diet

Interventions

PUFA-diet OTHER

Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: polyunsaturated fatty acid diet (PUFA) will have P/S ratio 1.0.

P/S-ratio 1.0

SAFA-diet OTHER

Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: Saturated fatty acid diet (SAFA) will polyunsaturated/saturated (P/S) ratio of 0.3.

P/S-ration 0.3

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \>20kg/m2 \<29kg/m2
• Pro12Pro and Ala12Ala genotypes of PPARG Pro12Ala polymorphism
• participation to METSIM-study (METabolic Syndrome in Men, currently \>10000 men included from the population living in Kuopio, principal investigator Markku Laakso)
• normoglycemia

You may not qualify if:

• type 2 diabetes
• other chronic diseases

Sponsors & Collaborators

• Marjukka Kolehmainen: lead
• Kuopio University Hospital: collaborator

Study Sites (1)

University of Eastern Finland

Kuopio, FIN-70211, Finland

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jussi Pihlajamäki, Professor

  University of Eastern Finland, Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

• Ursula S Schwab, Clinical Lect, adjunct prof

  University of Eastern Finland

  STUDY DIRECTOR

• Matti Uusitupa, Professor

  Professor

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior scientist

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 11, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 17, 2012

Record last verified: 2012-04

Locations

FI (1)