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

Study Overview
=================
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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Authentic Ladotyri Mytilinis PDO cheese
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ladotyri Mytilinis PDO cheese, Postprandial response