Fatty Acid Desaturase Gene Locus Interactions With Diet (FADSDIET2)

NCT03572205 | Completed

• 1 other identifier: FADSDIET2
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatty Acids; Genetics

Keywords

Nutrigenetics

Outcome Measures

Primary Outcomes (1)

• Change in fatty acid composition of serum lipid fractions

  Fatty acid composition of serum lipid fractions

  8 weeks

Secondary Outcomes (3)

• Glucose and insulin metabolism response

  8 weeks

• Inflammatory markers response

  8 weeks

• Adipose tissue biopsies

  8 weeks

Study Arms (4)

CC genotype LA

EXPERIMENTAL

4-week study diet will be isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (5-6 % of energy intake) of sunflower oil (source of LA: linoleic acid) daily, depending on body weight. The same diet will be instructed for both genotypes.

Dietary Supplement: LA

TT genotype LA

EXPERIMENTAL

4-week study diet will be isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (5-6 % of energy intake) of sunflower oil (source of LA: linoleic acid) daily, depending on body weight. The same diet will be instructed for both genotypes.

Dietary Supplement: LA

CC genotype ALA

EXPERIMENTAL

4-week study diet will be isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (5-6 % of energy intake) of camelina oil (source of alpha-linolenic acid: ALA) daily, depending on body weight. The same diet will be instructed for both genotypes.

Dietary Supplement: ALA

TT genotype ALA

EXPERIMENTAL

4-week study diet will be isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (5-6 % of energy intake) of camelina oil (source of alpha-linolenic acid: ALA) daily, depending on body weight. The same diet will be instructed for both genotypes.

Dietary Supplement: ALA

Interventions

LA DIETARY_SUPPLEMENT

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.

Also known as: sunflower oil

CC genotype LA; TT genotype LA

ALA DIETARY_SUPPLEMENT

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.

Also known as: camelina oil

CC genotype ALA; TT genotype ALA

Eligibility Criteria

• Age: 50 Years - 65 Years
• Gender Eligibility Details: Men because the population source for recruitment Metabolic syndrome in men (METSIM) study is composed solely by men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of METSIM study cohort with CC/TT FADS1 rs174547 SNP genotype.
• BMI 20-32 kg/m2.
• Healthy .

You may not qualify if:

• Diagnosis of type 2 diabetes.
• Diagnosis of chronic diseases and conditions, that may hamper the ability to follow the dietary intervention protocol
• Chronic liver, thyroid and kidney diseases
• Alcohol abuse (\> 40 g/d)
• BMI \>32 kg/m2.

Sponsors & Collaborators

• University of Eastern Finland: lead

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

Location

MeSH Terms

Interventions

Sunflower Oil

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Jussi Pihlajamäki, MD

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: June 28, 2018
• Study Start: August 13, 2018
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)