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

Alice Andreassi

Status: Unknown

Conditions: Insulin Resistance

Treatments: Other: Placebo; Dietary Supplement: Inofolic Combi

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03920787

2017/ST/222

Details and patient eligibility

About

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.

Enrollment: 23 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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23 participants in 2 patient groups, including a placebo group

Inositol

Experimental group

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

Treatment:

Dietary Supplement: Inofolic Combi

Placebo

Placebo Comparator group

Description:

Administration of placebo. 2 capsules every day for 1 month

Treatment:

Other: Placebo