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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

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE December 3, 2013
Last Update Posted Date December 3, 2013
Study Start Date  ICMJE May 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
  • Framingham score changes [ Time Frame: 0, 12, 16 and 28 week ]
    Framingham score adapted to Spanish population (cardiovascular risk measurement)
  • Inflammatory markers changes [ Time Frame: 0, 12, 16 and 28 week ]
    Parameters measured were: Adiponectin, fibrinogen, TNFα, IL6, IL1B, PAI-1 and PCR
  • 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).
  • 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).
  • Blood pressure and heart rate changes [ Time Frame: 0, 12, 16 and 28 week ]
  • 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%).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 25, 2013)
  • Homocystein levels changes [ Time Frame: 0, 12, 16 and 28 week ]
  • 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.
  • 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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Health Benefits of Functional Meat (With n-3 Fatty Acids and Rosemary Extract) on Low Risk for Cardiovascular Disease People
Official Title  ICMJE 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
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:
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Low Risk for Cardiovascular Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Functional Meet
    • Other: Control Meat
  • Placebo Comparator: Control Meat
    During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
    Interventions:
    • Other: Functional Meet
    • Other: Control Meat
Publications * Bermejo LM, López-Plaza B, Weber TK, Palma-Milla S, Iglesias C, Reglero G, Gómez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2013)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01999088
Other Study ID Numbers  ICMJE HULP-2889
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigación Hospital Universitario La Paz
Study Sponsor  ICMJE Instituto de Investigación Hospital Universitario La Paz
Collaborators  ICMJE Spanish Ministry of industry, tourism and trade
Investigators  ICMJE
Principal Investigator: Carmen Gomez-Candela, MD, PhD Hospital Universitario La Paz
PRS Account Instituto de Investigación Hospital Universitario La Paz
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP