Assessment Metabolic Flexibility in Middle-aged Individuals: The Nutritional Impact of Cheese Consumption
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorUniversity of Cagliari
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
45-65 years of age
BMI < 27
waist-to-hip ratio female<0.85; male < 0.98
Disqualifiers
metabolic diseases
Physical activity of competitive nature
Vegans and vegetarians
Intolerances and allergies to the foods under study
Trial design
Design model
Crossover
Treatments tested in this trial
kent'erbas cheese study
Dietary supplementNutritional intervention with "kent'erbas" pecorino from extensive farming with crossover and "industrial" pecorino from intensive farming
Treatment groups
105 Participants
are divided into 2 treatment groupsGroup A: "kent'erbas" pecorino from extensive farming with crossover Arm 1Experimental treatment 1 intervention
Group B: "industrial" pecorino from intensive farming with crossover Arm 2Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossoverSecondary outcomes
1
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
Time frame
After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossoverSponsors and contacts
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Source ClinicalTrials.gov