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NCT Number: NCT02543216

Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene

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.

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Key information

Conditions

Fatty Acid

Age range

50 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Eastern Finland, Clinical Nutrition

Kuopio, 70211, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunflower oil

Dietary Supplement

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%).

Primary outcomes

  1. Fatty acid profile of serum lipid fractions

    Time frame: 4 weeks

Secondary outcomes

  1. Serum lipids an lipoproteins

    Time frame: 4 weeks

  2. Adipose tissue biopsies

    Time frame: 4 weeks

  3. white blood cell samples

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Eastern Finland

Other

Registry information

Official study title

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

Acronym: FADSDIET

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2015
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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