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

Healthy Clinical Trial

— LadotyriCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05788887
• Other study ID #: BAP20060569
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: January 17, 2022

Study information

• Verified date: April 2023
• Source: University of the Aegean
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Authentic Ladotyri Mytilinis PDO cheese
Branding PDO cheese from Mytilini, purchasing by E.Thimelis Dairy S.A.
• Control
Branding Parmesan PDO cheese from Italy, supplied by LIDL Hellas

Locations

Country	Name	City	State
Greece	University of the Aegean	Myrina

Sponsors (2)

Lead Sponsor	Collaborator
University of the Aegean	E.Thimelis Dairy S.A.

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline of Total Antioxidant Capacity at 30 minutes, 1.5 hours and 3 hours	Plasma antioxidant activity	3 hours
Secondary	Changes from baseline of total Cholesterol at 30 minutes, 1.5 hours and 3 hours	Serum total cholesterol levels	3 hours
Secondary	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
Secondary	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
Secondary	Changes from baseline of triglycerides at 30 minutes, 1.5 hours and 3 hours	Serum triglycerides levels	3 hours
Secondary	Changes from baseline of glucose at 30 minutes, 1.5 hours and 3 hours	Serum glucose levels	3 hours
Secondary	Changes from baseline of Uric Acid at 30 minutes, 1.5 hours and 3 hours	Serum uric acid levels	3 hours