Assessment Metabolic Flexibility in Middle-aged Individuals: The Nutritional Impact of Cheese Consumption
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: kent'erbas cheese study.
- Who it may be relevant to
- Registry conditions: Metabolism, Nutrition. Basic parameters: 45 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Dietary supplement kent'erbas cheese study
Nutritional intervention with "kent'erbas" pecorino from extensive farming with crossover and "industrial" pecorino from intensive farming
Primary outcome measures
- Changes in plasma levels of DHA and acylethanolamides as Metabolic indices of PPAR-α induction increase in plasma levels of DHA [Time frame: After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover]
Secondary outcome measures (1)
- Quotient respiratory changes measurement as metabolic flexibility indices [Time frame: After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- University of Cagliari — Monserrato
Identifiers
NCT: NCT06012227 · UCagliari2