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Completed

NCT Number: NCT02813031

Human Study of Functional Meat Products

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IMDEA-Food

Madrid, 28049, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Functional meat products

Other

Traditional meat products

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

IMDEA Food

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2016
Registry last updated
Jun 24, 2016

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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