2.1. Study Design
cancer, diabetes mellitus, liver or kidney disease
CHRONIC ILLNESSES, LACTOSE INTOLERANCE, HYPERLIPIDEMIA, CVD, CANCER, DIABETES MELLITUS, HYPERTENSION
The current study is an exploratory sub-study of a double-blind randomized two-arm longitudinal crossover intervention trial [clinical trial: ISRCTN78753338] [Individuals were not considered for inclusion if they indicated chronic illnesses including cancer, overt hyperlipidemia, hypertension, diabetes mellitus or heart, liver or kidney disease and history of CVD. In addition, receiving anti-inflammatory medication or anticoagulant treatment during the study or during the two-week run-in period was also considered as a criterion for exclusion. Additional exclusion criteria included the following: use of lipid-lowering drugs, diuretics, or β-blockers, lactose intolerance, or being in a weight-loss program. Volunteers who ingested a spread enriched with PhyS or fish oil supplements or exhibited a pronounced aversion to dairy products were also disqualified from participation. A thorough physical examination administered by the study’s physician was conducted to verify the participants’ healthy condition.All study participants were instructed to maintain their usual diets throughout the study period (12 weeks), consistent with stable weight maintenance, and to continue their normal patterns of physical activity. Dietary and physical activity habits and rare changes were recorded by the volunteers in food frequency questionnaires and participants’ diaries. The diaries were delivered at each visit at the end of run-in period and the end of each phase of intervention period. Compliance was monitored through weekly telephone calls and personal interviews and with a written form in each period. The study received approval from the Human Ethical Review Committee of Hospital Santa Creu I Sant Pau (Barcelona), with the reference number 10/2011 and the date of approval being 5 July 2011. All participants gave informed written consent prior to inclusion.