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

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ClinicalTrials.gov Identifier: NCT02543216
Recruitment Status : Completed
First Posted : September 7, 2015
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Jussi Pihlajamäki, University of Eastern Finland

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 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.

Condition or disease Intervention/treatment Phase
Fatty Acid Dietary Supplement: Sunflower oil Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene (FADSDIET)
Study Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CC genotype
4-week 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. The same diets were instructed for both genotypes.
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%).

Experimental: TT genotype
4-week 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. The same diets were instructed for both genotypes.
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%).




Primary Outcome Measures :
  1. Fatty acid profile of serum lipid fractions [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02543216


Locations
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Finland
University of Eastern Finland, Clinical Nutrition
Kuopio, Finland, 70211
Sponsors and Collaborators
University of Eastern Finland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jussi Pihlajamäki, Professor, University of Eastern Finland
ClinicalTrials.gov Identifier: NCT02543216     History of Changes
Other Study ID Numbers: FADSDIET
First Posted: September 7, 2015    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015
Keywords provided by Jussi Pihlajamäki, University of Eastern Finland:
fatty acids, FADS gene, genotype, diet