Clinical trial NCT05788887: Investigation of the Postprandial Response of Two Different PDO Cheeses on Metabolic Biomarkers
Official title: Postprandial Inflammatory and Metabolic Responses Induced by the Authentic Ladotyri Mytilinis PDO Cheese and Italian Parmesan PDO Cheese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Ladotyri Mytilinis PDO cheese
Postprandial response
Lead sponsor: University of the Aegean
Sponsor class: OTHER
Collaborators: name: E.Thimelis Dairy S.A.
First posted: 2023-03-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Changes from baseline of Total Antioxidant Capacity at 30 minutes, 1.5 hours and 3 hours
timeFrame: 3 hours
Secondary outcomes:
measure: Changes from baseline of total Cholesterol at 30 minutes, 1.5 hours and 3 hours
timeFrame: 3 hours
measure: Changes from baseline of High Density Lipoprotein cholesterol (HDL-) at 30 minutes, 1.5 hours and 3 hours
timeFrame: 3 hours
measure: Changes from baseline of Low Density Lipoprotein cholesterol (LDL-) at 30 minutes, 1.5 hours and 3 hours
timeFrame: 3 hours
measure: Changes from baseline of triglycerides at 30 minutes, 1.5 hours and 3 hours
timeFrame: 3 hours
measure: Changes from baseline of glucose at 30 minutes, 1.5 hours and 3 hours
timeFrame: 3 hours
measure: Changes from baseline of Uric Acid at 30 minutes, 1.5 hours and 3 hours
timeFrame: 3 hours
Other outcomes:
Locations:
city: Myrina
country: Greece
facility: University of the Aegean
Study officials:
References: