Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07263802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy of GlycoDual on Postprandial Glycemic Control and Insulin Sensitivity in Subjects With Impaired Glucose Metabolism: a Randomized, Controlled, Double-blind Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Secondary objectives are to estimate:
* the change of insulin sensitivity (HOMA-IR)
* the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
Secondary objectives are to estimate:
* the change of insulin sensitivity (HOMA-IR)
* the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
Detailed Description:
Mild dysglycemias, such as impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), represent pre-diabetic conditions characterized by a subclinical impairment of insulin sensitivity and β-cell function. Early intervention in this phase can prevent or delay the progression to full-blown diabetes. In this context, the use of nutraceutical supplements with physiological activity on glucose metabolism represents a promising and well-tolerated approach, able to effectively modulate metabolic parameters, with a good safety profile. GlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Secondary objectives are to estimate:
* the change of insulin sensitivity (HOMA-IR)
* the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
Secondary objectives are to estimate:
* the change of insulin sensitivity (HOMA-IR)
* the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: