Assessment Metabolic Flexibility in Middle-aged Individuals: The Nutritional Impact of Cheese Consumption

NCT06012227 | Recruiting DMC

• 1 other identifier: UCagliari2
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

Metabolism; Nutrition

Keywords

metabolic flexibility; lipid metabolism

Outcome Measures

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

  After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover

Secondary Outcomes (1)

• Quotient respiratory changes measurement as metabolic flexibility indices

  After 4 weeks of treatment, 8 weeks of washout and 4 weeks of crossover

Study Arms (2)

"kent'erbas" pecorino from extensive farming with crossover Arm 1

EXPERIMENTAL

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

"industrial" pecorino from intensive farming with crossover Arm 2

ACTIVE COMPARATOR

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

Interventions

kent'erbas cheese study DIETARY_SUPPLEMENT

Nutritional intervention with "kent'erbas" pecorino from extensive farming with crossover and "industrial" pecorino from intensive farming

"industrial" pecorino from intensive farming with crossover Arm 2; "kent'erbas" pecorino from extensive farming with crossover Arm 1

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• BMI \< 27
• waist-to-hip ratio female\<0.85; male \< 0.98

You may not qualify if:

• metabolic diseases
• Physical activity of competitive nature
• Vegans and vegetarians
• Intolerances and allergies to the foods under study

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

University of Cagliari

Monserrato, Cagliari, 09042, Italy

RECRUITING

Central Study Contacts

Sebastiano Banni

CONTACT

070-6754128; banni@unica.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 25, 2023
• Study Start: January 20, 2022
• Primary Completion: July 27, 2023
• Study Completion (Estimated): December 20, 2026
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

IT (1)