Clinical trial NCT01999088: Health Benefits of Functional Meat (With n-3 Fatty Acids and Rosemary Extract) on Low Risk for Cardiovascular Disease People
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Risk for Cardiovascular Disease
Keywords: Fatty Acids, Omega-3
Rosemary extract
Functional meat
Cardiovascular disease
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Spanish Ministry of industry, tourism and trade
First posted: 2013-12-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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:

Eligibility criteria: 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.

Primary outcomes:
measure: Lipid profile changes
timeFrame: 0, 12, 16 and 28 week
Secondary outcomes:
measure: Framingham score changes
timeFrame: 0, 12, 16 and 28 week
measure: Inflammatory markers changes
timeFrame: 0, 12, 16 and 28 week
measure: Oxidative Stress Parameters changes
timeFrame: 0, 12, 16 and 28 week
measure: Glucosa Metabolism changes
timeFrame: 0, 12, 16 and 28 week
measure: Blood pressure and heart rate changes
timeFrame: 0, 12, 16 and 28 week
measure: Anthropometric parameters changes
timeFrame: 0, 12, 16 and 28 week
Other outcomes:
measure: Homocystein levels changes
timeFrame: 0, 12, 16 and 28 week
measure: Sensory perception
timeFrame: 12, and 28 week
measure: Adverse event
timeFrame: 12, and 28 week
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
state: Maadrid
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gomez-Candela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bermejo LM, Lopez-Plaza B, Weber TK, Palma-Milla S, Iglesias C, Reglero G, Gomez-Candela C. Impact of cooked functional meat enriched with omega-3 fatty acids and rosemary extract on inflammatory and oxidative status; a randomised, double-blind, crossover study. Nutr Hosp. 2014 Nov 1;30(5):1084-91. doi: 10.3305/nh.2014.30.5.8048.