Investigation of the Postprandial Response of Two Differe... | NCT05788887

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

NCT05788887

Sponsor

University of the Aegean

Status

Completed

Last Update Posted

Apr 14, 2023Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

Authentic Ladotyri Mytilinis PDO cheese
Control

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2022Actual

Primary Completion Date

Jan 17, 2022Actual

Completion Date

Jan 17, 2022Actual

First Submitted Date

Feb 24, 2023

First Submission Date that Met QC Criteria

Mar 16, 2023

First Posted Date

Mar 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 11, 2023

Last Update Posted Date

Apr 14, 2023Actual

Name	Class
E.Thimelis Dairy S.A.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	The meal contained 100g of white wheat bread and 80g of Italian Parmesan PDO cheese.	Other: Control
Intervention	Other	The meal contained 100g of white wheat bread and 80g of Authentic Ladotyri Mytilinis PDO cheese.	Other: Authentic Ladotyri Mytilinis PDO cheese

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Authentic Ladotyri Mytilinis PDO cheese	Other	Branding PDO cheese from Mytilini, purchasing by E.Thimelis Dairy S.A.	Intervention

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of the Aegean		Myrina		81 400	Greece

IPD Sharing Statement Module

Plan to Share IPD

Description

No individual participant data are to be shared.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Dec 16, 2022	Apr 11, 2023	Prot_SAP_ICF_001.pdf

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.