Assessment Metabolic Flexibility in Middle-aged Individuals: The Nutritional Impact of Cheese Consumption

Study Overview
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Brief Summary
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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 transcription factor PPAR-α determined by the gene expression of PPAR-α in white blood cells, variations in circulating fatty acid metabolism, and the endocannabinoid system determined by circulating analysis of N-acylethanolamine (NAE), and 2-monoacylglycerols (2-MG); Metabolic flexibility, determined by indirect calorimetry in fasting condition during an incremental exercise; Body composition, determined by bioimpedance analysis, waist circumference, and waist-to-hip ratio.

Detailed Description
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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.

Official Title
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Assessment Metabolic Flexibility by Indirect Calorimetry and Circulating Metabolic Parameters in Middle-aged Individuals: The Nutritional Impact of Cheese From Extensive and Intensive Farming.

Conditions
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Metabolism, Nutrition

Intervention / Treatment
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* Dietary Supplement: kent'erbas cheese study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45-65 years of age BMI < 27 waist-to-hip ratio female<0.85; male < 0.98 Exclusion Criteria: metabolic diseases Physical activity of competitive nature Vegans and vegetarians Intolerances and allergies to the foods under study

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: kent'erbas pecorino from extensive farming with crossover Arm 1<br>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<br>* Nutritional intervention with kent'erbas pecorino from extensive farming with crossover and industrial pecorino from intensive farming<br>|
| Active Comparator: industrial pecorino from intensive farming with crossover Arm 2<br>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<br>* Nutritional intervention with kent'erbas pecorino from extensive farming with crossover and industrial pecorino from intensive farming<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic flexibility, lipid metabolism