An interventional study of kent'erbas cheese study in Metabolism and Nutrition, sponsored by University of Cagliari. Recruiting at 1 site in Italy. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by University of Cagliari · Not applicable, Interventional, and Treatment
The aim of the study will be to evaluate the impact of consumption of meat and dairy products from extensive or intensive farming on apparently healthy individuals aged between 45 and 65 years, a stage of life associated with reduced metabolic flexibility and changes in lipid metabolism.
The study will analyze:
The study will be a double-blind crossover intervention clinical trial conducted on the aforementioned individuals, who will consume "kent'erbas" cheese products, from extensive and intensive farming.
The study will include 105 individuals aged between 45 and 65 years, apparently in good health, recruited from the UTIC cardiology unit of A.O.U.CA Cagliari (Italy). All participants will be provided with a detailed explanation of the study procedures and its purpose, and their participation will be contingent upon signing an informed consent form. Throughout the study, subjects will maintain their regular lifestyle and unrestricted food intake.
At the outset of the study, relevant information necessary for an appropriate approach to each participant will be collected, including a comprehensive medical history, measurement of anthropometric parameters, and blood sampling for a thorough hematological, inflammatory, and lipid-metabolomic analysis.
In the pecorino study, subjects will consume 350g/week of "kent'erbas" pecorino from extensive farming or 350g/week of "industrial" pecorino from intensive farming for 4 weeks in total. At the end of this period, a blood sample will be taken. Subsequently, there will be a 8 weeks washout period during which participants will follow their usual diet without consuming either type of pecorino. At the end of the washout period, an additional blood sample will be taken. Following this, the participants who had consumed "kent'erbas" pecorino will switch to "industrial" pecorino for 4 weeks, and vice versa. At the end of this second period, a final blood sample will be collected.
The quantities of pecorino cheese chosen for intake are representative of the average consumption in Italy.
University of Cagliari is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This study was a 4-week, randomized, controlled, crossover clinical trial. Arm 1: Volunteers will be randomize to be allocated to eat 350g/week of "kent'erbas" pecorino from extensive farming with a crossover with arm 2 after 6 weeks of washout.
Dietary Supplement: kent'erbas cheese study
This study was a 4-week, randomized, controlled, crossover clinical trial. Arm 2 : Volunteers will be randomize to be allocated to eat 350g/week of "industrial" pecorino from intensive farming for 4 weeks in total, with a crossover with arm 1 after 6 weeks of washout.
Dietary Supplement: kent'erbas cheese study
Nutritional intervention with "kent'erbas" pecorino from extensive farming with crossover and "industrial" pecorino from intensive farming
Changes in plasma levels of DHA and acylethanolamides as Metabolic indices of PPAR-α induction increase in plasma levels of DHA
Changes in plasma levels of DHA)and modulation of the endocannabinoid system, through the biosynthesis of AEA, PEA, and OEA. All these parameters will be assessed as pmoles/ml of plasma
Time frame: After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover
Quotient respiratory changes measurement as metabolic flexibility indices
Metabolic flexibility indices, through fasting differences in the respiratory quotient, measured as Liter/min of Oxygen consumption and carbon dioxide
Time frame: After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover
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University of Cagliari