NCT02543216

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
Last Updated

September 10, 2015

Status Verified

September 1, 2015

Enrollment Period

3 months

First QC Date

September 3, 2015

Last Update Submit

September 9, 2015

Conditions

Fatty Acid

Keywords

fatty acids, FADS gene, genotype, diet

Outcome Measures

Primary Outcomes (1)

  • Fatty acid profile of serum lipid fractions

    4 weeks

Secondary Outcomes (3)

  • Serum lipids an lipoproteins

    4 weeks

  • Adipose tissue biopsies

    4 weeks

  • white blood cell samples

    4 weeks

Study Arms (2)

CC genotype

EXPERIMENTAL

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

TT genotype

EXPERIMENTAL

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

Interventions

Sunflower oilDIETARY_SUPPLEMENT

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%).

CC genotypeTT genotype

Eligibility Criteria

Age50 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant of Metabolic syndrome in men (METSIM) cohort BMI 20-30 kg/m2 Healthy CC/TT genotype (rs 174547)

You may not qualify if:

  • Type 2 diabetes Other chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland, Clinical Nutrition

Kuopio, 70211, Finland

Location

Related Publications (2)

  • 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.

    PMID: 34718859DERIVED

  • 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.

    PMID: 30624587DERIVED

MeSH Terms

Interventions

Sunflower Oil

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 7, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 10, 2015

Record last verified: 2015-09

Locations

FI(1)