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OpenTrials
Completed

NCT Number: NCT04107922

Nutraceutical on Hyperglycemia

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Glicoset

Dietary Supplement

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

Placebo

Other

Patients will take placebo

Primary outcomes

  1. Progression of dysglicemia

    Time frame: 3 months

    Oral glucose tolerance test

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2019
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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