Nutraceutical on Hyperglycemia

Sponsor

University of Pavia (Other)

Overall Status

Completed

CT.gov ID

NCT04107922

Collaborator

(none)

148

Enrollment

Location

Arms

Actual Duration (Months)

13.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysglycemia	Dietary Supplement: Glicoset Other: Placebo	Phase 3

Detailed Description

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

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 1, 2018

Actual Primary Completion Date :

Aug 31, 2019

Actual Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Glicoset Glicoset is a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate	Dietary Supplement: Glicoset Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
Placebo Comparator: Placebo	Other: Placebo Patients will take placebo

Arm

Intervention/Treatment

Active Comparator: Glicoset

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

Dietary Supplement: Glicoset

Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate

Placebo Comparator: Placebo

Other: Placebo

Patients will take placebo

Outcome Measures

Primary Outcome Measures

Progression of dysglicemia [3 months]
Oral glucose tolerance test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Policlinico San Matteo	Pavia	Lombardy	Italy	27100

Sponsors and Collaborators

University of Pavia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Giuseppe Derosa, MD, PhD, FESC, University of Pavia

ClinicalTrials.gov Identifier:

NCT04107922

Other Study ID Numbers:

P-20180016364

First Posted:

Sep 27, 2019

Last Update Posted:

Oct 1, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Oct 1, 2019