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

Instituto de Investigación Hospital Universitario La Paz

Status and phase: Completed; Phase 4

Conditions: Low Risk for Cardiovascular Disease

Treatments: Other: Functional Meet; Other: Control Meat

Study type: Interventional

Funder types: Other

Identifiers

NCT01999088

HULP-2889

Details and patient eligibility

About

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.

Full description

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:

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Functional meat

Experimental group

Description:

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.

Treatment:

Other: Control Meat

Other: Functional Meet

Control Meat

Placebo Comparator group

Description:

During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).

Treatment:

Other: Control Meat

Other: Functional Meet