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Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight

NCT03920787 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-04-22

No results posted yet for this study

Summary

Inositol in involved in the insulin pathway. In literature it has been demonstrated to improve insulin sensitivity and ovarian function in women affected by PCOS.

In a preliminary study conducted on obese children between 7 and 15 years, the investigators have demonstrated that Inositol administration (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg) before a Glucose Oral Tolerance Test reduces the increase of insulin levels, particularly in subjects with basal insulin ≥ 15 uU/ml.

So the aim of this study is to evaluate the potential therapeutic effect of inositol, as non-pharmacologic agent, in preventing tipe II diabetes in children.

Conditions

Interventions

DIETARY_SUPPLEMENT

Inofolic Combi

Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.

OTHER

Placebo

2 capsules every day for 1 month

Sponsors & Collaborators

  • Lo.Li.Pharma s.r.l

    collaborator INDUSTRY

  • Azienda Ospedaliera San Paolo

    collaborator OTHER

  • Alice Andreassi

    lead OTHER

Principal Investigators

  • Mario Mancini · AO San Paolo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-10
Primary Completion
2020-03-31
Completion
2020-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920787 on ClinicalTrials.gov