- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02543216
Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene (FADSDIET)
Gene - Diet Interactions in Fatty Acid Desaturase 1 Gene (FADSDIET)
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kuopio, Finland, 70211
- University of Eastern Finland, Clinical Nutrition
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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.
|
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.
|
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
Outcome Measure |
Time Frame |
---|---|
Fatty acid profile of serum lipid fractions
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
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
Sponsor
Publications and helpful links
General Publications
- Meuronen T, Lankinen MA, Karkkainen O, Laakso M, Pihlajamaki J, Hanhineva K, Schwab U. FADS1 rs174550 genotype and high linoleic acid diet modify plasma PUFA phospholipids in a dietary intervention study. Eur J Nutr. 2022 Mar;61(2):1109-1120. doi: 10.1007/s00394-021-02722-w. Epub 2021 Oct 31.
- Lankinen MA, Fauland A, Shimizu BI, Agren J, Wheelock CE, Laakso M, Schwab U, Pihlajamaki 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FADSDIET
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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