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

September 9, 2015 updated by: Jussi Pihlajamäki, University of Eastern Finland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
59

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • University of Eastern Finland, Clinical Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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%).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Fatty acid profile of serum lipid fractions
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Serum lipids an lipoproteins
Time Frame: 4 weeks
4 weeks
Adipose tissue biopsies
Time Frame: 4 weeks
4 weeks
white blood cell samples
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Eastern Finland

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FADSDIET

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