Clinical trial NCT02813031: Human Study of Functional Meat Products
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: functional meat products
hypocaloric fats
diglyceride
obesity
Lead sponsor: IMDEA Food
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Changes in waist circumference
timeFrame: Before and after 8 weeks
Secondary outcomes:
measure: Changes in lipid profile
timeFrame: Before and after 8 weeks
measure: Changes in fat depots
timeFrame: Before and after 8 weeks
measure: Changes in blood clotting and endothelial function
timeFrame: Before and after 8 weeks
measure: Product safety
timeFrame: Before and after 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IMDEA-Food
Study officials:
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.