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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

Tracking Information
First Submitted Date  ICMJE June 17, 2016
First Posted Date  ICMJE June 24, 2016
Last Update Posted Date June 24, 2016
Study Start Date  ICMJE April 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • 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
  • Changes in fat depots [ Time Frame: Before and after 8 weeks ]
    To evaluate changes in fat depots leptin levels will be measured
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Study of Functional Meat Products
Official Title  ICMJE 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
Brief Summary Nutritional clinical trial to evaluate the effectiveness of different functional meat products on the nutritional status of healthy people
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Other: Functional meat products
  • Other: Traditional meat products
Study Arms  ICMJE
  • 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
    Intervention: Other: Functional meat products
  • Placebo Comparator: Traditional meat products
    Healthy people consuming the same amount of traditional meat products
    Intervention: Other: Traditional meat products
Publications *

*   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: June 21, 2016)
78
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 NCT02813031
Other Study ID Numbers  ICMJE IMD PI014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Viviana Loria Kohen, IMDEA Food
Study Sponsor  ICMJE IMDEA Food
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IMDEA Food
Verification Date June 2016

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