NCT04107922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

September 25, 2019

Last Update Submit

September 27, 2019

Conditions

Dysglycemia

Outcome Measures

Primary Outcomes (1)

  • Progression of dysglicemia

    Oral glucose tolerance test

    3 months

Study Arms (2)

Glicoset

ACTIVE COMPARATOR

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

Dietary Supplement: Glicoset

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

GlicosetDIETARY_SUPPLEMENT

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

Glicoset
PlaceboOTHER

Patients will take placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
  • Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, FESC

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

October 1, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Locations

IT(1)