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

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.

Study Overview

• Status: Completed
• Conditions: Low Risk for Cardiovascular Disease
• Intervention / Treatment: Other: Functional Meet; Other: Control Meat

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:

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Maadrid
    • Madrid, Maadrid, Spain, 28046
      • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homocystein levels changes		0, 12, 16 and 28 week
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
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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Spanish Ministry of industry, tourism and trade
• Investigators: Principal Investigator: Carmen Gomez-Candela, MD, PhD, Hospital Universitario La Paz

Publications and helpful links

General Publications

• 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.

Helpful Links

• Institute for Health Research IdiPAZ
• Research group in Nutrition and Functional Foods (NUTRINVEST)

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2013
• Last Update Submitted That Met QC Criteria: November 25, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Fatty Acids, Omega-3; Rosemary extract; Functional meat
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: HULP-2889