Studies
EPIC Potsdam
EPIC-Potsdam is a large-scale prospective cohort study involving 27,548 participants from the general population. For analyses on biomarkers and genetic information, a case-cohort study within the study was designed. We randomly selected individuals (subcohort) from the EPIC-Potsdam study population. Together with the incident cases of T2DM and CVD, this subcohort forms the case-cohort study population to be used in FAME.
http://www.dife.de/de/forschung/projekte/epic.php
http://epic.iarc.fr/centers/germany.php
CORDIOPREV
The CORDIOPREV study is an ongoing prospective, opened RCT in 1002 patients with coronary heart disease enrolling in two different dietary models (MedDiet and low-fat) over a period of seven years, in addition to conventional treatment for coronary heart disease. Participants free of diabetes at baseline (n=462) are the basis for lipidomics measurements to investigate relationships with the incidence of T2DM in an observational approach.
http://www.cordioprev.es/index.php/en/
PREDIMED
In the PREDIMED trial participants at high CVD risk (n=7447) were randomly assigned to one of three whole diet based interventions. Two of the groups were based on a traditional MedDiet pattern, one supplemented with extra virgin olive oil (EVOO) and the other with mixed nuts. The third group was advised to follow a low-fat diet. The median follow-up was 4.8y. In the current FAME project, a cost-effective prospective case-cohort design is proposed. PREDIMED cases include all participants who experienced a confirmed primary CVD event (myocardial infarction, stroke or CVD death) in the trial through December 1 2010, and who had samples available both at baseline and after one year of intervention (n=226). The subcohort comprises a random 10% subsample (n=781 including 37 overlapping cases) of all participants at baseline (n=7,447).
FLAVURS
FLAVURS (n=154) is an 18 week fruit and vegetable (F&V) intervention, where the impact of 2, 4, or 6 portions of flavonoid (polyphenol) rich vs. flavonoid poor F&V (each for 6 weeks) vs. control (habitual diet) on vascular and cardiometabolic health was determined in UK adults (n=180). Its dose-response approach and controlled and detailed information on polyphenol intake provide a design highly suited to investigate the impact of polyphenol intakes on FAs and lipidomic profiles.
http://www.isrctn.com/ISRCTN47748735
CIRCLES
CIRCLES is a 6 months parallel dose-response intervention in n=120 adults with the metabolic syndrome, evaluating the impact of 2 doses of anthocyanins (polyphenols, fed as blueberry extract) vs. control on insulin sensitivity, liver fat and other measures of cardiometabolic health.
https://clinicaltrials.gov/ct2/show/NCT02035592
LIPGENE, RESET, DIVAS, SATgene
LIPGENE (n=417), SATgene (n=90), DIVAS (n=195), and RESET (n=54) are existing RCTs evaluating specific FA modulations and cardiometabolic health.
LIPGENE is a large chronic study examining the response to quality and quantity of dietary fat and carbohydrate (high SFA; high MUFA; low fat; low fat/n-3PUFA) over a period of 4 months.
https://dashin.eu/interventionstudies/study/show/20294522
RESET is an intervention study specifically modifying the intake of SFA from bovine sources. All of these studies include repeated blood collection (baseline, follow-up) and collection of cardiometabolic phenotypes and detailed dietary data.
https://clinicaltrials.gov/ct2/show/NCT02089035
SATgene is a chronic study investigating the impact of APOE genotype on the response to dietary fat manipulation (Low-fat diet, High-fat diet and High-fat diet supplemented with LC n-3 PUFA).
https://clinicaltrials.gov/ct2/show/NCT01384032
DIVAS is a 4-month parallel chronic intervention study comparing different dietary FA manipulations (SFA, n6 PUFA or MUFA).