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NCT04107922 Clinical Trial

Nutraceutical on Hyperglycemia

Dysglycemia Clinical Trial

Official title:
Metabolic Actions of a Supplement of Ilex Paraguariensis, White Mulberry and Chromium Picolinate in Non-diabetic Subjects With Dysglycemia, a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04107922
Other study ID # P-20180016364
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 1, 2018
Est. completion date August 31, 2019

Study information
Verified date September 2019
Source University of Pavia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 148
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Glicoset
Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
Other:
• Placebo
Patients will take placebo

Locations
Country Name City State
Italy IRCCS Policlinico San Matteo Pavia Lombardy

Sponsors (1)
Lead Sponsor Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression of dysglicemia Oral glucose tolerance test 3 months
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