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Trial record 28 of 55 for:    linolenic acid

Fatty Acid Desaturase Gene Locus Interactions With Diet (FADSDIET2) (FADSDIET2)

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ClinicalTrials.gov Identifier: NCT03572205
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
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. 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.

Condition or disease Intervention/treatment Phase
Fatty Acids Genetics Dietary Supplement: LA Dietary Supplement: ALA Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fatty Acid Desaturase Gene Locus Interactions With Diet (FADSDIET2)
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : December 19, 2018
Actual Study Completion Date : December 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CC genotype LA
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
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.
Other Name: sunflower oil

Experimental: TT genotype LA
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
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.
Other Name: sunflower oil

Experimental: CC genotype ALA
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
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.
Other Name: camelina oil

Experimental: TT genotype ALA
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
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.
Other Name: camelina oil




Primary Outcome Measures :
  1. Change in fatty acid composition of serum lipid fractions [ Time Frame: 8 weeks ]
    Fatty acid composition of serum lipid fractions


Secondary Outcome Measures :
  1. Glucose and insulin metabolism response [ Time Frame: 8 weeks ]
    Oral glucose tolerance test (OGTT) variables: fasting, 30 min and 120 min glucose and insulin measurements

  2. Inflammatory markers response [ Time Frame: 8 weeks ]
    Serum circulating levels of high-sensitivity C-reactive protein

  3. Adipose tissue biopsies [ Time Frame: 8 weeks ]
    Subcutaneous adipose tissue taken by open biopsy to collect 1-5 g of adipose tissue.



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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men because the population source for recruitment Metabolic syndrome in men (METSIM) study is composed solely by men.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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): NCT03572205


Locations
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Finland
University of Eastern Finland
Kuopio, Finland, 70211
Sponsors and Collaborators
University of Eastern Finland
Investigators
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Principal Investigator: Jussi Pihlajamäki, MD University of Eastern Finland

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Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT03572205     History of Changes
Other Study ID Numbers: FADSDIET2
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Eastern Finland:
Nutrigenetics