HealthyLadotyriCTNCT05788887
Investigation of the Postprandial Response of Two Different PDO Cheeses on Metabolic Biomarkers
A study testing Authentic Ladotyri Mytilinis PDO cheese in people with Healthy, run by University of the Aegean at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Authentic Ladotyri Mytilinis PDO cheese
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2022to 17 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Willingness to join and complete the nutritional intervention
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postprandial Inflammatory and Metabolic Responses Induced by the Authentic Ladotyri Mytilinis PDO Cheese and Italian Parmesan PDO Cheese
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Authentic Ladotyri Mytilinis PDO cheese, Control
- Keywords
- Ladotyri Mytilinis PDO cheese, Postprandial response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Authentic Ladotyri Mytilinis PDO cheeseOther
Branding PDO cheese from Mytilini, purchasing by E.Thimelis Dairy S.A.
ControlOther
Also called Italian Parmesan
Branding Parmesan PDO cheese from Italy, supplied by LIDL Hellas
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The meal contained 100g of white wheat bread and 80g of Italian Parmesan PDO cheese. Receives: Other: Control |
| Intervention | Other | The meal contained 100g of white wheat bread and 80g of Authentic Ladotyri Mytilinis PDO cheese. Receives: Other: Authentic Ladotyri Mytilinis PDO cheese |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of Total Antioxidant Capacity at 30 minutes, 1.5 hours and 3 hours
Plasma antioxidant activity
Measured: 3 hours
Secondary outcomes (6)
Changes from baseline of total Cholesterol at 30 minutes, 1.5 hours and 3 hours
Serum total cholesterol levels
Measured: 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
Measured: 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
Measured: 3 hours
Changes from baseline of triglycerides at 30 minutes, 1.5 hours and 3 hours
Serum triglycerides levels
Measured: 3 hours
Changes from baseline of glucose at 30 minutes, 1.5 hours and 3 hours
Serum glucose levels
Measured: 3 hours
Changes from baseline of Uric Acid at 30 minutes, 1.5 hours and 3 hours
Serum uric acid levels
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start10 Jan 2022
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Aegean
- Sponsor type
- University, hospital or other
- Collaborators
- E.Thimelis Dairy S.A.
- Responsible party
- Principal investigator, ANTONIOS KOUTELIDAKIS, University of the Aegean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788887
- Sponsor's protocol ID
- BAP20060569
- Acronym
- LadotyriCT
- Status last verified
- Apr 2023
- First submitted
- 24 Feb 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data are to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Inflammatory and Metabolic Responses Induced by the Authentic Ladotyri Mytilinis PDO Cheese and Italian Parmesan PDO Cheese
- ClinicalTrials.gov ID
- NCT05788887
- Acronym / sponsor ID
- LadotyriCT / BAP20060569
- Conditions
- Healthy
- Keywords
- Ladotyri Mytilinis PDO cheese, Postprandial response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of the AegeanUniversity, hospital or other
- Collaborators
- E.Thimelis Dairy S.A.
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlThe meal contained 100g of white wheat bread and 80g of Italian Parmesan PDO cheese. |
| Intervention | Other | Other: Authentic Ladotyri Mytilinis PDO cheeseThe meal contained 100g of white wheat bread and 80g of Authentic Ladotyri Mytilinis PDO cheese. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-65 years
- Willingness to join and complete the nutritional intervention
Key exclusion criteria (10 listed)
- 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 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Authentic Ladotyri Mytilinis PDO cheeseBranding PDO cheese from Mytilini, purchasing by E.Thimelis Dairy S.A. | Other | Intervention |
| ControlAlso: Italian ParmesanBranding Parmesan PDO cheese from Italy, supplied by LIDL Hellas | Other | Control |
Primary outcome
Changes from baseline of Total Antioxidant Capacity at 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Plasma antioxidant activity
6 secondary outcomes
Changes from baseline of total Cholesterol at 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes from baseline of High Density Lipoprotein cholesterol (HDL-) at 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes from baseline of Low Density Lipoprotein cholesterol (LDL-) at 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes from baseline of triglycerides at 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes from baseline of glucose at 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Changes from baseline of Uric Acid at 30 minutes, 1.5 hours and 3 hours
Time frame: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No. No individual participant data are to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Authentic Ladotyri Mytilinis PDO cheese in people with Healthy, run by University of the Aegean at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline of Total Antioxidant Capacity at 30 minutes, 1.5 hours and 3 hours (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.