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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06012227
Other study ID # UCagliari2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date December 20, 2026

Study information

Verified date August 2023
Source University of Cagliari
Contact Sebastiano Banni
Phone 070-6754128
Email banni@unica.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date December 20, 2026
Est. primary completion date July 27, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
kent'erbas cheese study
Nutritional intervention with "kent'erbas" pecorino from extensive farming with crossover and "industrial" pecorino from intensive farming

Locations

Country Name City State
Italy University of Cagliari Monserrato Cagliari

Sponsors (1)

Lead Sponsor Collaborator
University of Cagliari

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in plasma levels of DHA and acylethanolamides as Metabolic indices of PPAR-a 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 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
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