Nutraceutical on Hyperglycemia

University of Pavia

Status and phase: Completed; Phase 3

Conditions: Dysglycemia

Treatments: Other: Placebo; Dietary Supplement: Glicoset

Study type: Interventional

Funder types: Other

Identifiers

NCT04107922

P-20180016364

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups, including a placebo group

Glicoset

Active Comparator group

Description:

Glicoset is a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate

Treatment:

Dietary Supplement: Glicoset

Placebo

Placebo Comparator group

Treatment:

Other: Placebo