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

NCT07263802 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

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

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • Fondazione IRCCS Policlinico San Matteo di Pavia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-01-31
Completion
2026-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07263802 on ClinicalTrials.gov