Metabolic Actions of a Supplement of Ilex Paraguariensis, White Mulberry and Chromium Picolinate in Non-diabetic Subjects With Dysglycemia, a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Pavia
- Enrollment
- 148
- Locations
- 1
- Primary Endpoint
- Progression of dysglicemia
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Placebo
Intervention: Placebo (Other)
Glicoset
Glicoset is a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
Intervention: Glicoset (Dietary Supplement)
Outcomes
Primary Outcomes
Progression of dysglicemia
Time Frame: 3 months
Oral glucose tolerance test
Secondary Outcomes
No secondary outcomes reported
Investigators
Giuseppe Derosa
MD, PhD, FESC
University of Pavia