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Human Study of Functional Meat Products

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ClinicalTrials.gov Identifier: NCT02813031
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
Viviana Loria Kohen, IMDEA Food

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Functional meat products Other: Traditional meat products Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: Functional meat products with healthy lipids from olive oil
Healthy people consuming 300g/week of functional meat products with high diglyceride lipid from olive oil
Other: Functional meat products
Placebo Comparator: Traditional meat products
Healthy people consuming the same amount of traditional meat products
Other: Traditional meat products



Primary Outcome Measures :
  1. Changes in waist circumference [ Time Frame: Before and after 8 weeks ]
    The waist circumference (WC) was measured using a Seca 201 inelastic tape (Quirumed, Valencia, Spain).


Secondary Outcome Measures :
  1. Changes in lipid profile [ Time Frame: Before and after 8 weeks ]

    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

  2. Changes in fat depots [ Time Frame: Before and after 8 weeks ]
    To evaluate changes in fat depots leptin levels will be measured

  3. Changes in blood clotting and endothelial function [ Time Frame: Before and after 8 weeks ]

    To evaluate changes in blood clotting and endothelial function will be taken into account:

    • PAI I
    • Fibrinogen

  4. Product safety [ Time Frame: Before and after 8 weeks ]

    To con trol the safety of the products the following variables will be measured:

    • Urea
    • Creatinine
    • GOT
    • GPT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02813031


Locations
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Spain
IMDEA-Food
Madrid, Spain, 28049
Sponsors and Collaborators
IMDEA Food
Publications:
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Responsible Party: Viviana Loria Kohen, Senior Researcher, Nutrition PhD in Medicine, IMDEA Food
ClinicalTrials.gov Identifier: NCT02813031    
Other Study ID Numbers: IMD PI014
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: June 2016
Keywords provided by Viviana Loria Kohen, IMDEA Food:
functional meat products
hypocaloric fats
diglyceride
obesity