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.
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.
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 (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.
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.
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.
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.
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).
DIVAS is a 4-month parallel chronic intervention study comparing different dietary FA manipulations (SFA, n6 PUFA or MUFA).