Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene

Fatty Acid Clinical Trial

— FADSDIET  

Official title:

Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene (FADSDIET)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543216
• Other study ID #: FADSDIET
• Status: Completed
• Phase: N/A
• First received: September 3, 2015
• Last updated: September 9, 2015
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: University of Eastern Finland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: University of Eastern Finland
• Study type: Interventional

Clinical Trial Summary

Interactions between genes and environment, are likely to be crucial in the development of the common diseases such as type 2 diabetes. It was recently shown that FADS1 and FADS 2 genotypes are the strongest genes in a genome-wide analysis regulating serum fatty acid profile.The aim of this study is to test if subjects with the CC and TT genotypes of the FADS1 gene (rs174547) respond differentially to a diet supplemented with linoleic acid (substrate for FADS). We hypothesize that subjects with the TT genotype with more active desaturases will be more sensitive to dietary modification leading to more robust differences in serum FA profile, tissue inflammation and serum lipids.

Description:

Lean and overweight subjects (BMI >20kg/m2 <29kg/m2 ) with CC and TT genotypes of FADS1 polymorphism (rs174547) were recruited from the METSIM study (METabolic Syndrome in Men, currently >10000 men included from the population living in Kuopio). The potential participants were asked to contact study nurse if willing to participate. Twenty six subjects with CC genotype were selected after matching with thirty six subjects with the TT genotype for age, BMI and medication.

Study diet were isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (25-45 g) sunflower oil daily depending on body weight. Thus, approximately 16-28 g (6 E%) LA daily were provided on top of the average intake of approximately 10-12 g (4.5 E%). This dose of sunflower oil is not known to cause any side effects or adverse events and even higher doses have been safe.

Food records were collected at the beginning (4 days) and during the third week of the study (7 days) to estimate daily intake of macronutrients and specifically of different fatty acids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 65 Years

Eligibility

Inclusion Criteria:

Participant of Metabolic syndrome in men (METSIM) cohort BMI 20-30 kg/m2 Healthy CC/TT genotype (rs 174547)

Exclusion Criteria:

Type 2 diabetes Other chronic disease

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Acid

Intervention

Dietary Supplement:
• Sunflower oil
Study diets were isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (25-45 g) sunflower oil daily depending on body weight. Thus, approximately 16-28 g (6 E%) LA were provided daily on top of the average intake of approximately 10-12 g (4.5 E%).

Locations

Country	Name	City	State
Finland	University of Eastern Finland, Clinical Nutrition	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatty acid profile of serum lipid fractions		4 weeks	No
Secondary	Serum lipids an lipoproteins		4 weeks	No
Secondary	Adipose tissue biopsies		4 weeks	No
Secondary	white blood cell samples		4 weeks	No