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

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ClinicalTrials.gov Identifier: NCT01999088
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : December 3, 2013
Sponsor:
Collaborator:
Spanish Ministry of industry, tourism and trade
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

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.


Condition or disease Intervention/treatment Phase
Low Risk for Cardiovascular Disease Other: Functional Meet Other: Control Meat Phase 4

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:

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : May 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

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 Name: 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 Name: 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 Name: 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 Name: Control Food




Primary Outcome Measures :
  1. Lipid profile changes [ Time Frame: 0, 12, 16 and 28 week ]
    Parameters measured were: Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Apolipoprotein B and Apolipoprotein A.


Secondary Outcome Measures :
  1. Framingham score changes [ Time Frame: 0, 12, 16 and 28 week ]
    Framingham score adapted to Spanish population (cardiovascular risk measurement)

  2. Inflammatory markers changes [ Time Frame: 0, 12, 16 and 28 week ]
    Parameters measured were: Adiponectin, fibrinogen, TNFα, IL6, IL1B, PAI-1 and PCR

  3. Oxidative Stress Parameters changes [ Time Frame: 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).

  4. Glucosa Metabolism changes [ Time Frame: 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).

  5. Blood pressure and heart rate changes [ Time Frame: 0, 12, 16 and 28 week ]
  6. Anthropometric parameters changes [ Time Frame: 0, 12, 16 and 28 week ]
    Parameters measured were: Weight, Height and waist circumference, tricipital skinfold thickness and fat mass percentage (FM%).


Other Outcome Measures:
  1. Homocystein levels changes [ Time Frame: 0, 12, 16 and 28 week ]
  2. Sensory perception [ Time Frame: 12, and 28 week ]
    Subjects were asked to value taste and smell meats consumed, using a Visual Analogical Scale ranged 1-10 cm.

  3. Adverse event [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999088


Locations
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Spain
Hospital Universitario La Paz
Madrid, Maadrid, Spain, 28046
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz
Spanish Ministry of industry, tourism and trade
Investigators
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Principal Investigator: Carmen Gomez-Candela, MD, PhD Hospital Universitario La Paz

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01999088     History of Changes
Other Study ID Numbers: HULP-2889
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: November 2013
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
Fatty Acids, Omega-3
Rosemary extract
Functional meat
Cardiovascular disease
Additional relevant MeSH terms:
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Cardiovascular Diseases