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

NCT07263802 | Not Yet Recruiting

• 1 other identifier: GDUAL-2025-RCT01
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impaired Glucose Tolerance (Prediabetes); Impaired Fasting Glucose (IFG)

Keywords

dysglycemia; Gymnema sylvestre; Zinc bisglycinate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Insulin sensitivity

  90 days

• Change in uricemia

  90 days

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Patients taking nutraceutical

Dietary Supplement: GlycoDual

Placebo

PLACEBO COMPARATOR

Patients taking placebo

Other: Placebo

Interventions

GlycoDual DIETARY_SUPPLEMENT

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

Intervention

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Giuseppe Derosa, MD

CONTACT

+390382502614; g.derosa@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Giuseppe Derosa

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share