Clinical trial NCT06012227: Assessment Metabolic Flexibility in Middle-aged Individuals: The Nutritional Impact of Cheese Consumption
Official title: Assessment Metabolic Flexibility by Indirect Calorimetry and Circulating Metabolic Parameters in Middle-aged Individuals: The Nutritional Impact of Cheese From Extensive and Intensive Farming.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolism
Nutrition
Keywords: metabolic flexibility
lipid metabolism
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 105
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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:

1. 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);
2. Metabolic flexibility, determined by indirect calorimetry in fasting condition during an incremental exercise;
3. Body composition, determined by bioimpedance analysis, waist circumference, and waist-to-hip ratio.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in plasma levels of DHA and acylethanolamides as Metabolic indices of PPAR-α induction increase in plasma levels of DHA
timeFrame: After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover
Secondary outcomes:
measure: Quotient respiratory changes measurement as metabolic flexibility indices
timeFrame: After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: University of Cagliari
state: Cagliari
Study officials:
References: