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| Name | Class |
|---|---|
| Spanish Ministry of industry, tourism and trade | UNKNOWN |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional meat | Experimental | 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. |
|
| Control Meat | Placebo Comparator | During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Gomez-Candela, MD, PhD | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Maadrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25365012 | Derived | 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. |
| Label | URL |
|---|---|
| Institute for Health Research IdiPAZ | View source |
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|
| Control Meat | Other | During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)). |
|
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D055951 | Functional Food |
| D064088 | Hazard Analysis and Critical Control Points |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D059022 | Food Safety |
| D063427 | Food Quality |
| D005524 | Food Technology |
| D019649 | Food Industry |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
| D012449 | Safety |
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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