Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia

University of Pavia

Status and phase: Completed; Phase 3

Conditions: Dysglycemia

Treatments: Other: Placebo; Dietary Supplement: Reglicem

Study type: Interventional

Funder types: Other

Identifiers

NCT04107987

P-20180017962

Details and patient eligibility

About

Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.

Full description

Dysglycemia is an important pre-risk condition which can potentially lead to diabetes if not adequately treated. The variation of glycemic balance can lead to cardiovascular disorders. The study will evaluate if Reglicem®, a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate, can ameliorate glycemic status in patients with dysglycemia.

The investigators will enroll patients with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT), not taking other hypoglycemic compounds. Patients will be randomized to take Reglicem® or placebo for 3 months, in a randomized, double-blind, placebo-controlled design. Reglicem® 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: Quadruple Blind

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148 participants in 2 patient groups, including a placebo group

Reglicemi

Active Comparator group

Description:

Reglicemi is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate

Treatment:

Dietary Supplement: Reglicem

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo