Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03572205
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2018-06-13
Brief Title:
Fatty Acid Desaturase Gene Locus Interactions With Diet FADSDIET2
Sponsor:
University of Eastern Finland
Organization:
University of Eastern Finland
Study Overview
Official Title:
Fatty Acid Desaturase Gene Locus Interactions With Diet FADSDIET2
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FADSDIET2
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 profileThe 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 20kgm2 32kgm2 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 1214 vs 420 mol respectively after the diet enriched in LA from preliminary data Considering a β080 and an α0025 instead of only 005 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
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 1214 vs 420 mol respectively after the diet enriched in LA from preliminary data Considering a β080 and an α0025 instead of only 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None