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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorFondazione IRCCS Policlinico San Matteo di Pavia

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • GlycoDual
  • Placebo

Treatment groups

90 Participants
are divided into 2 treatment groups

Locations

This trial has no locations