Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose Metabolism

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Impaired Fasting Glucose (IFG); Impaired Glucose Tolerance (Prediabetes)
• Intervention / Treatment: Other: Placebo; Dietary supplement: GlycoDual

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Derosa, MD; Phone Number: +390382502614; Email: g.derosa@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• body mass index (BMI) 25.0-29.9 kg/m2
• FPG levels between 100 and 125 mg/dl [IFG diagnosed after Oral Glucose Tolerance Test (OGTT)]
• HOMA-IR > 2.5
• subjects able to understand the informed consent and sign it before enrollment in the study

Exclusion Criteria:

• personal history of cardiovascular disease or equivalent risk factors
• obesity (BMI ≥ 30 kg/m²)
• taking hypoglycemic drugs or supplements that affect glycemic metabolism
• diabetes mellitus or IGT
• pregnancy or breastfeeding
• known thyroid, liver, kidney or muscle diseases
• any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent
• any known allergy or hypersensitivity to one or more components of the food supplement

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients taking placebo	Other: Placebo; Placebo
Active Comparator: Intervention; Patients taking nutraceutical	Dietary supplement: GlycoDual; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on glycemia	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.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Insulin sensitivity	The secondary objective will be to evaluate the efficacy of GlycoDual in reducing insulin sensitivity (HOMA-IR) levels compared to placebo after 90 days of treatment.	90 days
Change in uricemia	The secondary objective will be to evaluate the efficacy of GlycoDual in reducing uricemia levels compared to placebo after 90 days of treatment.	90 days

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: dysglycemia; Gymnema sylvestre; Zinc bisglycinate
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperglycemia; Nutritional and Metabolic Diseases; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: GDUAL-2025-RCT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No