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

Primary Purpose

Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Inofolic Combi
Placebo
Sponsored by
Alice Andreassi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance focused on measuring inositol, insulin resistance, overweight, children

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 8-18 years old
  • overweight or obesity
  • basal insulin ≥ 20 uU/ml

Exclusion Criteria:

  • pubertal delay
  • hypogonadism
  • hypothyroidism or hyperthyroidism
  • obesity-related genetic diseases

Sites / Locations

  • AO San PaoloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Inositol

Placebo

Arm Description

Administration of Inofolic Combi (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg - Lo.Li Pharma S.r.l.) 2 capsules every day for 1 month

Administration of placebo. 2 capsules every day for 1 month

Outcomes

Primary Outcome Measures

Basal Insulin
Evaluation of the efficacy of inositol in reducing basal insulin

Secondary Outcome Measures

Body weight
Evaluation of the efficacy of inositol in reducing body weight

Full Information

First Posted
April 16, 2019
Last Updated
April 18, 2019
Sponsor
Alice Andreassi
Collaborators
Lo.Li.Pharma s.r.l, Azienda Ospedaliera San Paolo
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1. Study Identification

Unique Protocol Identification Number
NCT03920787
Brief Title
Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight
Official Title
Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alice Andreassi
Collaborators
Lo.Li.Pharma s.r.l, Azienda Ospedaliera San Paolo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
inositol, insulin resistance, overweight, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inositol
Arm Type
Experimental
Arm Description
Administration of Inofolic Combi (Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg - Lo.Li Pharma S.r.l.) 2 capsules every day for 1 month
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administration of placebo. 2 capsules every day for 1 month
Intervention Type
Dietary Supplement
Intervention Name(s)
Inofolic Combi
Intervention Description
Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
2 capsules every day for 1 month
Primary Outcome Measure Information:
Title
Basal Insulin
Description
Evaluation of the efficacy of inositol in reducing basal insulin
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Body weight
Description
Evaluation of the efficacy of inositol in reducing body weight
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 8-18 years old overweight or obesity basal insulin ≥ 20 uU/ml Exclusion Criteria: pubertal delay hypogonadism hypothyroidism or hyperthyroidism obesity-related genetic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Mancini
Phone
00393331009479
Email
mancinis178@msn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Andreassi
Phone
00393401799869
Email
aliceandreassi2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Mancini
Organizational Affiliation
AO San Paolo
Official's Role
Study Director
Facility Information:
Facility Name
AO San Paolo
City
Milan
State/Province
Mi
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Mancini
Phone
00393331009479
Email
mancinis178@msn.com
First Name & Middle Initial & Last Name & Degree
Alice Andreassi
Phone
00393401799860
Email
aliceandreassi2@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27882052
Citation
Mancini M, Andreassi A, Salvioni M, Pelliccione F, Mantellassi G, Banderali G. Myoinositol and D-Chiro Inositol in Improving Insulin Resistance in Obese Male Children: Preliminary Data. Int J Endocrinol. 2016;2016:8720342. doi: 10.1155/2016/8720342. Epub 2016 Nov 1.
Results Reference
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Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight

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