Health Benefits of Functional Meat (With n-3 Fatty Acids and Rosemary Extract) on Low Risk for Cardiovascular Disease People

Study Overview
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Brief Summary
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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.

Detailed Description
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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:

Official Title
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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

Conditions
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Low Risk for Cardiovascular Disease

Intervention / Treatment
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* Other: Functional Meet
* Other: Control Meat


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional meat<br>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. | Other: Functional Meet<br>* 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.<br>* Other names: Functional food;Other: Control Meat<br>* During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).<br>* Other names: Control Food;|
| Placebo Comparator: Control Meat<br>During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)). | Other: Functional Meet<br>* 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.<br>* Other names: Functional food;Other: Control Meat<br>* During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).<br>* Other names: Control Food;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipid profile changes | Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Apolipoprotein B and Apolipoprotein A. | 0, 12, 16 and 28 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Framingham score changes | Framingham score adapted to Spanish population (cardiovascular risk measurement) | 0, 12, 16 and 28 week | 
| Inflammatory markers changes | Parameters measured were: Adiponectin, fibrinogen, TNFα, IL6, IL1B, PAI-1 and PCR | 0, 12, 16 and 28 week | 
| Oxidative Stress Parameters changes | Parameters measured were: plasma antioxidant capacity (FRAP, ferric reducing antioxidant power), lipidic peroxidation (TBARS, thiobarbituric acid reactive substances assay), LDL-ox, . 8-iso-Prostaglandin F2α (8-iso-PGF2α), α-tocopherol and nitric oxide synthase (NOS). | 0, 12, 16 and 28 week | 
| Glucosa Metabolism changes | Parameters measured were: glucose, basal insulin, HOMA index (glycemic insulin sensitivity index was calculated using the formula: HOMA-IR = fasting glucose (mmol/l)/fasting immunoreactive insulin (mU/ml)/22.5). | 0, 12, 16 and 28 week | 
| Blood pressure and heart rate changes |  | 0, 12, 16 and 28 week | 
| Anthropometric parameters changes | Parameters measured were: Weight, Height and waist circumference, tricipital skinfold thickness and fat mass percentage (FM%). | 0, 12, 16 and 28 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatty Acids, Omega-3, Rosemary extract, Functional meat, Cardiovascular disease