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Completed

NCT Number: NCT05788887

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of the Aegean

Myrina, 81 400, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Authentic Ladotyri Mytilinis PDO cheese

Other

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

Control

Other

Branding Parmesan PDO cheese from Italy, supplied by LIDL Hellas

Other names: Italian Parmesan

Primary outcomes

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

    Time frame: 3 hours

    Plasma antioxidant activity

Secondary outcomes

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

    Time frame: 3 hours

    Serum total cholesterol levels

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

    Time frame: 3 hours

    Serum High Density Lipoprotein levels

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

    Time frame: 3 hours

    Serum High Density Lipoprotein levels

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

    Time frame: 3 hours

    Serum triglycerides levels

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

    Time frame: 3 hours

    Serum glucose levels

  6. Changes from baseline of Uric Acid at 30 minutes, 1.5 hours and 3 hours

    Time frame: 3 hours

    Serum uric acid levels

Sponsors and collaborators

Lead sponsor

University of the Aegean

Other

Collaborators

  • E.Thimelis Dairy S.A.

Registry information

Official study title

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

Acronym: LadotyriCT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2023
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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