Investigation of the Postprandial Response of Two Different PDO Cheeses on Metabolic Biomarkers (LadotyriCT)

Postprandial Inflammatory and Metabolic Responses Induced by the Authentic Ladotyri Mytilinis PDO Cheese and Italian Parmesan PDO Cheese

The purpose of this study was the investigation of the postprandial metabolic responses, after the intake of a traditional, Ladotyri Mytilinis cheese, compared to corresponding responses after an Italian Parmesan cheese consumption, in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Control; Other: Authentic Ladotyri Mytilinis PDO cheese

Detailed Description

A pilot cross-over, randomized and single-blinded, intervention-clinical trial was conducted, in ten healthy men and women subjects, aged eighteen to thirty years, after random allocation into the control and the intervention group, received a high-fat and carbohydrates meal, containing Ladotyri Mytilinis (the authentic nonrefrigerated recipe) or Italian Parmesan, PDO cheeses. After a washout week, participants consumed the same meals, conversely. Differences on postprandial responses of serum total, High Density Lipoprotein (HDL-), Low Density Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as well as of plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power method, were determined between groups in fasting, thirty minutes, one and a half hour, and three hours after meal intake.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Myrina, Greece, 81 400
    • University of the Aegean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age 18-65 years
• Willingness to join and complete the nutritional intervention

Exclusion Criteria:

• Inability or unwillingness to provide informed consent
• Three-month nutritional supplement
• Age over 65 years or below 18 years
• Chronic diseases history
• Hemoglobin A1c - HbA1c > 5.7 %
• Abnormal Body Mass Index (BMI) (> 25 kg / m2)
• Abnormal hematological or biochemical profile (total cholesterol > 240 mg/dL, triglycerides > 250 mg/dL, glucose > 100 mg/dL)
• Alcohol overdose (> 40 g alcohol / day)
• Heavy smoking (> 10 cigarettes / day)
• Concurrent participation in another intervention study or unconsciousness in previous blood draws

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; The meal contained 100g of white wheat bread and 80g of Italian Parmesan PDO cheese.	Other: Control; Branding Parmesan PDO cheese from Italy, supplied by LIDL Hellas; Other Names: Italian Parmesan
Other: Intervention; The meal contained 100g of white wheat bread and 80g of Authentic Ladotyri Mytilinis PDO cheese.	Other: Authentic Ladotyri Mytilinis PDO cheese; Branding PDO cheese from Mytilini, purchasing by E.Thimelis Dairy S.A.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline of Total Antioxidant Capacity at 30 minutes, 1.5 hours and 3 hours	Plasma antioxidant activity	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline of total Cholesterol at 30 minutes, 1.5 hours and 3 hours	Serum total cholesterol levels	3 hours
Changes from baseline of High Density Lipoprotein cholesterol (HDL-) at 30 minutes, 1.5 hours and 3 hours	Serum High Density Lipoprotein levels	3 hours
Changes from baseline of Low Density Lipoprotein cholesterol (LDL-) at 30 minutes, 1.5 hours and 3 hours	Serum High Density Lipoprotein levels	3 hours
Changes from baseline of triglycerides at 30 minutes, 1.5 hours and 3 hours	Serum triglycerides levels	3 hours
Changes from baseline of glucose at 30 minutes, 1.5 hours and 3 hours	Serum glucose levels	3 hours
Changes from baseline of Uric Acid at 30 minutes, 1.5 hours and 3 hours	Serum uric acid levels	3 hours

Collaborators and Investigators

• Sponsor: University of the Aegean
• Collaborators: E.Thimelis Dairy S.A.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): January 17, 2022

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Postprandial response; Ladotyri Mytilinis PDO cheese
• Other Study ID Numbers: BAP20060569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data are to be shared.

Drug and device information, study documents

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