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

Not Applicable

• Conditions: Insulin Resistance
• Interventions: Other: Placebo; Dietary Supplement: Inofolic Combi

• Registration Number: NCT03920787
• Lead Sponsor: Alice Andreassi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-10
• Status Verified: 2019-04
• Study First Submitted: 2019-04-16
• Study First Submitted QC: 2019-04-16
• Last Update Submitted: 2019-04-18
• Study First Posted: 2019-04-19
• Last Update Posted: 2019-04-22
• Primary Completion: 2020-03
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Administration of placebo. 2 capsules every day for 1 month
Inositol	Inofolic Combi	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

Primary Outcome Measures

Name	Time	Method
Basal Insulin	1 month	Evaluation of the efficacy of inositol in reducing basal insulin

Secondary Outcome Measures

Name	Time	Method
Body weight	1 month	Evaluation of the efficacy of inositol in reducing body weight

Trial Locations

Locations (1)

AO San Paolo; 🇮🇹 Milan, Mi, Italy