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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario La Paz | Madrid | Maadrid |
| Lead Sponsor | Collaborator |
|---|---|
| Instituto de Investigación Hospital Universitario La Paz | Spanish Ministry of industry, tourism and trade |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Homocystein levels changes | 0, 12, 16 and 28 week | No | |
| Other | Sensory perception | Subjects were asked to value taste and smell meats consumed, using a Visual Analogical Scale ranged 1-10 cm. | 12, and 28 week | No |
| Other | Adverse event | 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). | 12, and 28 week | Yes |
| Primary | Lipid profile changes | Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Apolipoprotein B and Apolipoprotein A. | 0, 12, 16 and 28 week | No |
| Secondary | Framingham score changes | Framingham score adapted to Spanish population (cardiovascular risk measurement) | 0, 12, 16 and 28 week | No |
| Secondary | Inflammatory markers changes | Parameters measured were: Adiponectin, fibrinogen, TNFa, IL6, IL1B, PAI-1 and PCR | 0, 12, 16 and 28 week | No |
| Secondary | 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 F2a (8-iso-PGF2a), a-tocopherol and nitric oxide synthase (NOS). | 0, 12, 16 and 28 week | Yes |
| Secondary | 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 | No |
| Secondary | Blood pressure and heart rate changes | 0, 12, 16 and 28 week | No | |
| Secondary | 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 | No |