NCT04107987

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

An Evaluation of a Nutraceutical With Berberine, Curcumin, Inositol, Banaba and Chromium Picolinate in Patients With Fasting Dysglycemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: University of Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Dysglycemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Reglicem	Reglicem is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate
OTHER	Placebo	Placebo

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-08-31
• Completion: 2019-08-31
• First posted: 2019-09-27
• Last updated: 2019-10-02

Locations

1 site across 1 country: Italy