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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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%).

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Finland

University of Eastern Finland, Clinical Nutrition

Kuopio, Finland, 70211

Sponsors and Collaborators

University of Eastern Finland

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lankinen MA, Fauland A, Shimizu BI, Ågren J, Wheelock CE, Laakso M, Schwab U, Pihlajamäki J. Inflammatory response to dietary linoleic acid depends on FADS1 genotype. Am J Clin Nutr. 2019 Jan 1;109(1):165-175. doi: 10.1093/ajcn/nqy287.

• 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
• 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