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

NCT05788887 | Completed

• 1 other identifier: BAP20060569
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Ladotyri Mytilinis PDO cheese; Postprandial response

Outcome Measures

Primary Outcomes (1)

• Changes from baseline of Total Antioxidant Capacity at 30 minutes, 1.5 hours and 3 hours

  Plasma antioxidant activity

  3 hours

Secondary Outcomes (6)

• Changes from baseline of total Cholesterol at 30 minutes, 1.5 hours and 3 hours

  3 hours

• Changes from baseline of High Density Lipoprotein cholesterol (HDL-) at 30 minutes, 1.5 hours and 3 hours

  3 hours

• Changes from baseline of Low Density Lipoprotein cholesterol (LDL-) at 30 minutes, 1.5 hours and 3 hours

  3 hours

• Changes from baseline of triglycerides at 30 minutes, 1.5 hours and 3 hours

  3 hours

• Changes from baseline of glucose at 30 minutes, 1.5 hours and 3 hours

  3 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

The meal contained 100g of white wheat bread and 80g of Italian Parmesan PDO cheese.

Other: Control

Intervention

OTHER

The meal contained 100g of white wheat bread and 80g of Authentic Ladotyri Mytilinis PDO cheese.

Other: Authentic Ladotyri Mytilinis PDO cheese

Interventions

Authentic Ladotyri Mytilinis PDO cheese OTHER

Branding PDO cheese from Mytilini, purchasing by E.Thimelis Dairy S.A.

Intervention

Control OTHER

Branding Parmesan PDO cheese from Italy, supplied by LIDL Hellas

Also known as: Italian Parmesan

Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Aegean: lead
• E.Thimelis Dairy S.A.: collaborator

Study Sites (1)

University of the Aegean

Myrina, 81 400, Greece

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only investigator knew the type of meal, consumed by each participant
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Antonios E. Koutelidakis

Model Details: In the first trial period, participants in arm a consumed a meal containing 100g of white wheat bread and 80g of Italian Parmesan PDO cheese and arm b participants consumed a meal containing 100g of white wheat bread and 80g of Authentic Ladotyri Mytilinis PDO cheese. After a washout week participants consumed the meals, in reverse.

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 29, 2023
• Study Start: January 10, 2022
• Primary Completion: January 17, 2022
• Study Completion: January 17, 2022
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)