Human Study of Functional Meat Products

Study Overview
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Brief Summary
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Nutritional clinical trial to evaluate the effectiveness of different functional meat products on the nutritional status of healthy people

Detailed Description
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Different studies have revealed that many chronic pathologies including cardiovascular disease, diabetes, autoimmune disorders, cancer, obesity or neurological diseases, could be influenced by different dietary components, such as lipids. Thus, looking for ways to substitute healthier lipids for fats that contain high amounts of cholesterol, saturated fatty acids or trans fat, could be of great interest in the prevention of chronic diseases. Currently, meat and meat products, especially those where the fat is one of the main ingredients of the formulation, are perceived as unhealthy foods associated with increased risk of cardiovascular disease, cancer and obesity development. This is mainly due to their content of fat, trans fat, high percentage of saturated fatty acids, and cholesterol. Examples include sausages, meat spreads, salami or mortadella. Interestingly, despite the negative perception, meat and meat products continue to hold a relevant position in the diet of the developed countries. Indeed, the group meat, poultry, deli meats and offal contribute to the 17% of the total dietary fat intake of the Spanish population. Moreover, the consumption of deli meats and other meat products represents 5.8% of the total caloric intake. These values support the increased interest in evaluating the effect of improving the composition of these products in the prevention of disease. Overweight and obesity are main public health concerns worldwide. They both contribute to the development of numerous diseases increasing the morbidity and mortality rates of the adult population. In this context, it is suggested that the incorporation of healthier fats may be of great interest in the prevention of these conditions. Thus, usage of lipids from olive oil as fats replacements in meat products could be an interesting strategy for the prevention and treatment of overweight and obesity. A randomized, controlled, nutritional intervention is proposed to evaluate the effect of functional meat products on body composition and lipid profile in healthy individuals.

Official Title
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Nutritional Intervention Study to Evaluate the Effect of an Olive Oil Lipid Rich in Diglycerides as a Fat Replacement in Different Meat Products, in a Healthy Population

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Functional meat products
* Other: Traditional meat products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between 18 - 65 years old. BMI >20<27 Adequate education level and comprehension of the clinical study. Willingness to participate in the study as a volunteer and to provide written consent. Exclusion Criteria: Diagnosis of Type I Diabetes . BMI >27 Dyslipidemia under pharmacological treatment. High blood pressure. Dementia, neurological disease or reduction of cognitive function. Severe illness (hepatic disease, renal disease, etc.). Refusal to consume the experimental or control meat products (e.g. Vegetarians) Refusal to follow healthy eating guidelines. Taking medications that could affect the lipid and glycemic profiles (statins, fibrate, diuretics, corticoids, anti-inflammatory, hypoglucemic or insulin) 30 days before the beginning of the study. Taking medications or substances for weight loss management (15 days before the beginning of the study). Consideration to follow a weight loss diet during the duration of the study. Pregnancy or lactation. High intake of alcohol. Any other exclusion criteria that the main investigator considers relevant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional meat products with healthy lipids from olive oil<br>Healthy people consuming 300g/week of functional meat products with high diglyceride lipid from olive oil | Other: Functional meat products<br> <br> |
| Placebo Comparator: Traditional meat products<br>Healthy people consuming the same amount of traditional meat products | Other: Traditional meat products<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in waist circumference | The waist circumference (WC) was measured using a Seca 201 inelastic tape (Quirumed, Valencia, Spain). | Before and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in lipid profile | To evaluate lipid improvements the following measurements will be taking into account: Triglycerides Total Cholesterol Low Density Lipoprotein Very Low Density Lipoprotein High Density Lipoprotein Apolipoprotein B100 Apolipoprotein E Free fatty acids | Before and after 8 weeks | 
| Changes in fat depots | To evaluate changes in fat depots leptin levels will be measured | Before and after 8 weeks | 
| Changes in blood clotting and endothelial function | To evaluate changes in blood clotting and endothelial function will be taken into account: PAI I Fibrinogen | Before and after 8 weeks | 
| Product safety | To con trol the safety of the products the following variables will be measured: Urea Creatinine GOT GPT | Before and after 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional meat products, hypocaloric fats, diglyceride, obesity