Dysglycemia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTGlicoset
Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
OTHERPlacebo
Patients will take placebo
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of dysglicemia | 3 months | Oral glucose tolerance test |
Countries
Italy
Outcome results
None listed