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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Madrid, Spanje, 28049
- Imdea-Food
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
|
Placebo-vergelijker: Traditional meat products
Healthy people consuming the same amount of traditional meat products
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in waist circumference
Tijdsspanne: Before and after 8 weeks
|
The waist circumference (WC) was measured using a Seca 201 inelastic tape (Quirumed, Valencia, Spain).
|
Before and after 8 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Changes in lipid profile
Tijdsspanne: Before and after 8 weeks
|
To evaluate lipid improvements the following measurements will be taking into account:
|
Before and after 8 weeks
|
|
Changes in fat depots
Tijdsspanne: Before and after 8 weeks
|
To evaluate changes in fat depots leptin levels will be measured
|
Before and after 8 weeks
|
|
Changes in blood clotting and endothelial function
Tijdsspanne: Before and after 8 weeks
|
To evaluate changes in blood clotting and endothelial function will be taken into account:
|
Before and after 8 weeks
|
|
Product safety
Tijdsspanne: Before and after 8 weeks
|
To con trol the safety of the products the following variables will be measured:
|
Before and after 8 weeks
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- IMD PI014
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .