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Completed

NCT Number: NCT01999088

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

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.

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Key information

Conditions

Low Risk for Cardiovascular Disease Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario La Paz

Madrid, Maadrid, 28046, Spain

About this study

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:

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional Meet

Other

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

Control Meat

Other

During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).

Other names: Control Food

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Collaborators

  • Spanish Ministry of industry, tourism and trade

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 3, 2013
Registry last updated
Dec 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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