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Report for Clinical Trial NCT03572205

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Fatty Acid Desaturase Gene Locus Interactions With Diet (FADSDIET2)

Interactions between genes and environment, are likely to be crucial in the development of the common diseases such as type 2 diabetes. Recently, the investigators have obtained data that genotypes of genes encoding for fatty acid desaturases 1 and 2 (FADS1 and FADS2) 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 different genotypes of the FADS2 gene respond differently to a diet supplemented with linoleic acid or alpha-linolenic acid (substrates for FADS2). The study hypothesizes that subjects will be more sensitive to the dietary modifications according to their genotype leading to more robust differences in serum FA profile, tissue inflammation and serum lipids.

NCT03572205 Fatty Acids Genetics

2 Interventions

Name: LA

Description: The source of linoleic acid (LA) will be sunflower oil (62-63 % LA). The study diets will be isocaloric. The allowed weight change during the study is ± 2-3 %. The amount of supplementary oil will be calculated individually based on the calculated energy expenditure and adjusted, if necessary, during the study based on body weight measurements.
Type: Dietary Supplement
Group Labels: 2

CC genotype LA TT genotype LA

Name: ALA

Description: The source of alpha-linolenic acid (ALA) will be camelina sativa oil (30-35 % ALA). The study diets will be isocaloric. The allowed weight change during the study is ± 2-3 %. The amount of supplementary oil will be calculated individually based on the calculated energy expenditure and adjusted, if necessary, during the study based on body weight measurements.
Type: Dietary Supplement
Group Labels: 2

CC genotype ALA TT genotype ALA

Primary Outcomes

Description: Fatty acid composition of serum lipid fractions

Measure: Change in fatty acid composition of serum lipid fractions

Time: 8 weeks

Secondary Outcomes

Description: Oral glucose tolerance test (OGTT) variables: fasting, 30 min and 120 min glucose and insulin measurements

Measure: Glucose and insulin metabolism response

Time: 8 weeks

Description: Serum circulating levels of high-sensitivity C-reactive protein

Measure: Inflammatory markers response

Time: 8 weeks

Description: Subcutaneous adipose tissue taken by open biopsy to collect 1-5 g of adipose tissue.

Measure: Adipose tissue biopsies

Time: 8 weeks
Purpose: Other

Allocation: Randomized

Parallel Assignment

There is one SNP

SNPs

1 rs174547

Subcutaneous adipose tissue taken by open biopsy to collect 1-5 g of adipose tissue.. Inclusion Criteria: - Participants of METSIM study cohort with CC/TT FADS1 rs174547 SNP genotype.

Inclusion Criteria: - Participants of METSIM study cohort with CC/TT FADS1 rs174547 SNP genotype.


HPO Nodes