Low Risk for Cardiovascular Disease
Conditions
Keywords
Fatty Acids, Omega-3, Rosemary extract, Functional meat, Cardiovascular disease
Brief summary
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
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:
Interventions
OTHERFunctional Meet
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.
OTHERControl Meat
During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
Sponsors
Spanish Ministry of industry, tourism and trade
Instituto de Investigación Hospital Universitario La Paz
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile changes | 0, 12, 16 and 28 week | Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Apolipoprotein B and Apolipoprotein A. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative Stress Parameters changes | 0, 12, 16 and 28 week | 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). |
| Glucosa Metabolism changes | 0, 12, 16 and 28 week | 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). |
| Blood pressure and heart rate changes | 0, 12, 16 and 28 week | — |
| Anthropometric parameters changes | 0, 12, 16 and 28 week | Parameters measured were: Weight, Height and waist circumference, tricipital skinfold thickness and fat mass percentage (FM%). |
| Framingham score changes | 0, 12, 16 and 28 week | Framingham score adapted to Spanish population (cardiovascular risk measurement) |
| Inflammatory markers changes | 0, 12, 16 and 28 week | Parameters measured were: Adiponectin, fibrinogen, TNFα, IL6, IL1B, PAI-1 and PCR |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 12, and 28 week | Defined as any unfavourable, unintended effect reported by a subject or observed by the investigator during the study. All were recorded along with the symptoms involved (nausea, vomiting, diarrhoea, halitosis, constipation). |
| Homocystein levels changes | 0, 12, 16 and 28 week | — |
| Sensory perception | 12, and 28 week | Subjects were asked to value taste and smell meats consumed, using a Visual Analogical Scale ranged 1-10 cm. |
Countries
Spain
Outcome results
None listed