Viewing Study NCT02543216



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Last Modification Date: 2024-10-26 @ 11:49 AM
Study NCT ID: NCT02543216
Status: COMPLETED
Last Update Posted: 2015-09-10
First Post: 2015-09-03

Brief Title: Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene
Sponsor: University of Eastern Finland
Organization: University of Eastern Finland

Study Overview

Official Title: Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene FADSDIET
Status: COMPLETED
Status Verified Date: 2015-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FADSDIET
Brief 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 profileThe 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
Detailed Description: Lean and overweight subjects BMI 20kgm2 29kgm2 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 45 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None