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
| Registry | NCT01999088 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, crossover, masking: double, prevention |
| Enrollment | 44 (Actual) |
| Sponsor | Instituto de Investigación Hospital Universitario La Paz (Other); collaborators: Spanish Ministry of industry, tourism and trade |
| Conditions | Low Risk for Cardiovascular Disease |
| Interventions | Functional Meet, Control Meat (Other) |
| Dates | start 2009-05-01, primary completion 2010-06-01, completion 2010-06-01, first posted 2013-12-03, last updated 2013-12-03 |
| Locations | 1 site in Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Low Risk for Cardiovascular Disease All trials of Functional Meet All trials of Control Meat
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:
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Functional meat | Experimental | Other: Functional Meet; Other: Control Meat | 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. |
| Control Meat | Placebo comparator | Other: Functional Meet; Other: Control Meat | During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)). |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * Men and women aged over 18 years * At least 2 lipid profile parameters altered (TAG ≥150 mg /dl and/or total cholesterol ≥200 mg / dl and/or LDL ≥130 mg / dl and/or HDL ≥40mg/dl men or ≥ 50mg/dl women). * Signed informed consent Exclusion Criteria: * Individuals with body mass index (BMI) ≥ 35 kg/m2 * Individuals with Diabetes Mellitus insulin dependent * Individuals with disorders associated with eating behaviour * Individuals with consumption of omega 3 functional foods, fish oil or antioxidant supplements * Individuals inability to consume the test foods (ej. Vegetarians) * Individuals with special diet due to disease as celiac disease, chronic renal failure, etc. * Individuals with mental disease or low cognitive function. * Individuals with consumption of drugs to weight lost. * Individuals treated with drugs whose direct effect is on lipid profile (statins, fibrates, diuretics, corticosteroids or oral anti-inflammatory). * Individuals with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.). * Pregnant women or lactating. * Individuals with regular consumption of anti-inflammatory or glucocorticoids.
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Universitario La Paz | Madrid, Maadrid | Spain |