Low Risk for Cardiovascular Disease Clinical Trial
Official title:
Randomized, Double-blind, Cross-over Placebo-controlled Study to Assess the Functional Meat Products With n-3 and Rosemary Extract Fluid in Biochemical Markers of Cardiovascular Disease Related Risk in Subjects at Low Risk for Cardiovascular Disease
Volunteers were randomly assigned by gender to follow of two 12 weeks experimental periods:
intervention (I) and control (C) in different order (I/C or C/I). Both periods were
separated by a 4 weeks wash-out interval during which subjects returned to their usual diet:
During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM)
products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and
meat derivatives had to be excluded from the diet.
During the C period, volunteers consumed identical amounts of meat products that did not
include functional ingredients (Control Meat (CM)).
Functional meat (FM) products (Functional cooked Ham (FH) and Functional cooked Turkey
breast (FT)), were manufactured mixing the meats with the patented formula®
(P200402755.2004). The amount of supercritical rosemary extract, deodorized salmon oil and
vitamin E used was respectively, 0.02% w/w, 0.6% w/w, and 0.001% w/w.
Control meat (CM) products (Control cooked Ham (CH) and Control cooked Turkey (CT), were
prepared without addition of the functional ingredients.
The total duration of the study was 28 weeks: first experimental period 0-12 weeks, washout period 12-16 weeks second experimental period 16-28 weeks: ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention