Nutraceutical on Hyperglycemia

University of Pavia148 enrolled

Overview

The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia. The investigators will enroll patients with impaired fasting plasma glucose (IFG) or impaired glucose tolerance (IGT), not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents). Patients will be randomized to take placebo or Glicoset® 1000 for 3 months, in a randomized, double-blind, placebo-controlled design. Glicoset® 1000 and placebo will be self-administered once a day, 1 tablet during the breakfast.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

148

Conditions

Dysglycemia

Interventions

GlicosetDIETARY_SUPPLEMENT

Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate

PlaceboOTHER

Patients will take placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT) * Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents) Exclusion Criteria: * Patients with type 1 or type 2 diabetes mellitus * Patients with impaired hepatic function * Patient with impaired renal function * Patients with gastrointestinal disorders * Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke * Patients with weight change of \> 3 Kg during the preceding 3 months * Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse. * Patients taking (within the previous 3 months) hypoglycemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, anti-depressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics * Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.

Locations (1)

IRCCS Policlinico San Matteo

Pavia, Lombardy, Italy

Outcomes

Primary Outcomes

Progression of dysglicemia

Oral glucose tolerance test

Time frame: 3 months

Data from ClinicalTrials.gov

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