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Status unknownNCT03920787Updated Apr 22, 2019

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

An interventional study of Inofolic Combi and Placebo in Insulin Resistance, sponsored by Alice Andreassi. Status unknown at 1 site in Italy. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-04-22.

Sponsored by Alice Andreassi · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Mar 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
8 Years to 18 Years
Sex
All
01

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.

02

Conditions studied

  • Insulin Resistance

Keywords

  • inositol
  • insulin resistance
  • overweight
  • children
03

In context

Insulin Resistance

2,025 studies on the registry are indexed under Insulin Resistance; 308 are open to participants now.

This study's planned enrollment of 23 is below the median of 40 across 1,587 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

This is the only study on the registry with Alice Andreassi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pubertal delay
  • hypogonadism
  • hypothyroidism or hyperthyroidism
  • obesity-related genetic diseases
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
23 participants (estimated)

Study arms

  • Experimental
    Inositol

    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

    Dietary Supplement: Inofolic Combi

  • Placebo comparator
    Placebo

    Administration of placebo. 2 capsules every day for 1 month

    Other: Placebo

Interventions

  • Dietary supplementInofolic Combi

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

  • OtherPlacebo

    2 capsules every day for 1 month

06

What researchers measure

Primary outcomes

  1. Basal Insulin

    Evaluation of the efficacy of inositol in reducing basal insulin

    Time frame: 1 month

Secondary outcomes

  1. Body weight

    Evaluation of the efficacy of inositol in reducing body weight

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 27882052 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Mar 2020, 24 months after the start.

Of 577 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 24 months is close to that.

Counting every sponsor, half of 604 studies reached it within 23 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 16, 2019
First posted
Apr 19, 2019
StartActual
Mar 10, 2018
Primary completionEst.
Mar 2020
CompletionEst.
Apr 2020
Last update
Apr 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03920787
Lead sponsor
Alice Andreassi
Collaborators
Lo.Li.Pharma s.r.l, Azienda Ospedaliera San Paolo
Responsible party
Alice Andreassi (Principal Investigator, Azienda Ospedaliera San Paolo) — Sponsor-investigator
First posted
Apr 19, 2019
Start date
Mar 10, 2018
Primary completion
Mar 2020 (estimated)
Completion
Apr 2020 (estimated)
Last update
Apr 22, 2019

Study contacts

Mario Mancini
Contact
mancinis178@msn.com
00393331009479
Alice Andreassi
Contact
aliceandreassi2@gmail.com
00393401799869
Mario Mancini
study director · AO San Paolo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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