Assessment Metabolic Flexibility in Middle-aged Individuals: The Nutritional Impact of Cheese Consumption (Kent'Erbas)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nutrition; Metabolism
• Intervention / Treatment: Dietary supplement: kent'erbas cheese study

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sebastiano Banni; Phone Number: 070-6754128; Email: banni@unica.it

Study Locations

• Italy
  • Cagliari
    • Monserrato, Cagliari, Italy, 09042
      • Recruiting
      • University of Cagliari
      • Contact: Sebastiano Banni; Phone Number: 070-6754128; Email: banni@unica.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: "industrial" pecorino from intensive farming with crossover Arm 2; 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
Experimental: "kent'erbas" pecorino from extensive farming with crossover Arm 1; 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; Nutritional intervention with "kent'erbas" pecorino from extensive farming with crossover and "industrial" pecorino from intensive farming

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Cagliari

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): July 27, 2023
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: lipid metabolism; metabolic flexibility
• Other Study ID Numbers: UCagliari2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No