Fatty AcidsFADSDIET2NCT03572205
Fatty Acid Desaturase Gene Locus Interactions With Diet (FADSDIET2)
A study testing LA and ALA in people with Fatty Acids and Genetics, run by University of Eastern Finland at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatty Acids, Genetics
- What is being tested?
- LA and ALA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFinland
- Study dates
- 13 Aug 2018to 19 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants of METSIM study cohort with CC/TT FADS1 rs174547 SNP genotype.
- BMI 20-32 kg/m2.
- Healthy .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Lean and overweight subjects (Body mass index: BMI >20kg/m2 <32kg/m2 ) with CC and TT genotypes of FADS1 single nucleotide polymorphism (SNP) from the METabolic Syndrome in Men (METSIM) study, in which currently >10000 men are included from the population living in Kuopio, will be recruited. Seventy subjects with CC genotype will be selected after matching with the 70 subjects with the TT genotype for age and BMI.
After a 4-week run-in period, the subjects within each genotype group will be randomly assigned into two study groups according to medians of BMI, age and fasting plasma glucose concentration: in one group the diet will be enriched with linoleic acid (LA, sunflower oil) and in the other group with alpha-linolenic acid (ALA, camelina oil). The intervention will last for 8 weeks.
The sample size calculation is based on the observed change in arachidonic acid (AA) in the cholesterol esthers fraction between CC and TT genotypes (12.14 vs. 4.20 mol%, respectively) after the diet enriched in LA from preliminary data. Considering a β=0.80 and an α=0.025 instead of only 0.05 to account for the fact that we now have two dietary interventions instead of one, 31 participants in each study group would need to be included. Assuming around 15% of dropouts in this trial, a final sample size of 35 for each group is required.
The study diet will be isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (25-45 g) sunflower or camelina oil daily depending on body weight. The dose of each oil is not known to cause any side effects or adverse events and even higher doses have been safe.
Participants will record their daily oil consumption and 4-day food records will be collected at the beginning and two times during the intervention period to measure daily intake of macronutrients and specifically different fatty acids.
- Conditions
- Fatty Acids, Genetics
- Being tested
- LA, ALA
- Keywords
- Nutrigenetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LADietary supplement
Also called sunflower oil
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.
ALADietary supplement
Also called camelina oil
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: ALA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatty acid composition of serum lipid fractions
Fatty acid composition of serum lipid fractions
Measured: 8 weeks
Secondary outcomes (3)
Glucose and insulin metabolism response
Oral glucose tolerance test (OGTT) variables: fasting, 30 min and 120 min glucose and insulin measurements
Measured: 8 weeks
Inflammatory markers response
Serum circulating levels of high-sensitivity C-reactive protein
Measured: 8 weeks
Adipose tissue biopsies
Subcutaneous adipose tissue taken by open biopsy to collect 1-5 g of adipose tissue.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start13 Aug 2018
- Primary completion19 Dec 2018
- Study completion19 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty AcidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jussi Pihlajamäki, MD, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572205
- Sponsor's protocol ID
- FADSDIET2
- Acronym
- FADSDIET2
- Status last verified
- Apr 2019
- First submitted
- 13 Jun 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatty Acid Desaturase Gene Locus Interactions With Diet (FADSDIET2)
- ClinicalTrials.gov ID
- NCT03572205
- Acronym / sponsor ID
- FADSDIET2 / FADSDIET2
- Conditions
- Fatty Acids, Genetics
- Keywords
- Nutrigenetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 19 Dec 2018 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lean and overweight subjects (Body mass index: BMI >20kg/m2 <32kg/m2 ) with CC and TT genotypes of FADS1 single nucleotide polymorphism (SNP) from the METabolic Syndrome in Men (METSIM) study, in which currently >10000 men are included from the population living in Kuopio, will be recruited. Seventy subjects with CC genotype will be selected after matching with the 70 subjects with the TT genotype for age and BMI.
After a 4-week run-in period, the subjects within each genotype group will be randomly assigned into two study groups according to medians of BMI, age and fasting plasma glucose concentration: in one group the diet will be enriched with linoleic acid (LA, sunflower oil) and in the other group with alpha-linolenic acid (ALA, camelina oil). The intervention will last for 8 weeks.
The sample size calculation is based on the observed change in arachidonic acid (AA) in the cholesterol esthers fraction between CC and TT genotypes (12.14 vs. 4.20 mol%, respectively) after the diet enriched in LA from preliminary data. Considering a β=0.80 and an α=0.025 instead of only 0.05 to account for the fact that we now have two dietary interventions instead of one, 31 participants in each study group would need to be included. Assuming around 15% of dropouts in this trial, a final sample size of 35 for each group is required.
The study diet will be isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (25-45 g) sunflower or camelina oil daily depending on body weight. The dose of each oil is not known to cause any side effects or adverse events and even higher doses have been safe.
Participants will record their daily oil consumption and 4-day food records will be collected at the beginning and two times during the intervention period to measure daily intake of macronutrients and specifically different fatty acids.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CC genotype LA | Experimental | Dietary Supplement: LA4-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. |
| TT genotype LA | Experimental | Dietary Supplement: LA4-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. |
| CC genotype ALA | Experimental | Dietary Supplement: ALA4-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. |
| TT genotype ALA | Experimental | Dietary Supplement: ALA4-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. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants of METSIM study cohort with CC/TT FADS1 rs174547 SNP genotype.
- BMI 20-32 kg/m2.
- Healthy .
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAAlso: sunflower oilThe 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. | Dietary supplement | CC genotype LA, TT genotype LA |
| ALAAlso: camelina oilThe 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. | Dietary supplement | CC genotype ALA, TT genotype ALA |
Primary outcome
Change in fatty acid composition of serum lipid fractions
Time frame: 8 weeks
Fatty acid composition of serum lipid fractions
3 secondary outcomes
Glucose and insulin metabolism response
Time frame: 8 weeks
Inflammatory markers response
Time frame: 8 weeks
Adipose tissue biopsies
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Fatty Acids
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
Enrolling by invitation
Effect of Omega-3 Supplementation on Pregnant Outcomes and Inflammation Markers of Women Infected With HIV Using Antiretroviral Therapy
Pregnant HIV Positive Women
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jussi Pihlajamäki, MD principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LA and ALA in people with Fatty Acids and Genetics, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatty acid composition of serum lipid fractions (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.