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

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT05788887
• Lead Sponsor: University of the Aegean

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.

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 Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-01-17
• Study Completion: 2022-01-17
• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Changes from baseline of Total Antioxidant Capacity at 30 minutes, 1.5 hours and 3 hours	3 hours	Plasma antioxidant activity

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of the Aegean; 🇬🇷 Myrina, Greece