Human Study of Functional Meat Products

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Functional meat products; Other: Traditional meat products

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: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28049
    • Imdea-Food

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IMDEA Food

Publications and helpful links

General Publications

• Nagao T, Watanabe H, Goto N, Onizawa K, Taguchi H, Matsuo N, Yasukawa T, Tsushima R, Shimasaki H, Itakura H. Dietary diacylglycerol suppresses accumulation of body fat compared to triacylglycerol in men in a double-blind controlled trial. J Nutr. 2000 Apr;130(4):792-7. doi: 10.1093/jn/130.4.792.
• Pearson AM. (1997). Principles and applications in production of reduced and low fat products. In: Production and processing of healthy meat, poultry and fish products. Advances in meat research. Vol 11. Pearson AM, Dutson TR (Eds). Blackie Academic & Professional
• Rudkowska I, Roynette CE, Demonty I, Vanstone CA, Jew S, Jones PJ. Diacylglycerol: efficacy and mechanism of action of an anti-obesity agent. Obes Res. 2005 Nov;13(11):1864-76. doi: 10.1038/oby.2005.229.
• Saito S, Yamaguchi T, Shoji K, Hibi M, Sugita T, Takase H. Effect of low concentration of diacylglycerol on mildly postprandial hypertriglyceridemia. Atherosclerosis. 2010 Dec;213(2):539-44. doi: 10.1016/j.atherosclerosis.2010.07.062. Epub 2010 Aug 19.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 17, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Estimate): June 24, 2016
• Last Update Submitted That Met QC Criteria: June 21, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: obesity; functional meat products; hypocaloric fats; diglyceride
• Other Study ID Numbers: IMD PI014