Evaluating the Effect of Inositol Supplementation in Overweight Children on Basal Insulin and Body Weight
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|ClinicalTrials.gov Identifier: NCT03920787|
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Insulin Resistance||Dietary Supplement: Inofolic Combi Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance|
|Actual Study Start Date :||March 10, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||April 2020|
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
Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.
Placebo Comparator: Placebo
Administration of placebo. 2 capsules every day for 1 month
2 capsules every day for 1 month
- Basal Insulin [ Time Frame: 1 month ]Evaluation of the efficacy of inositol in reducing basal insulin
- Body weight [ Time Frame: 1 month ]Evaluation of the efficacy of inositol in reducing body weight
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920787
|Contact: Mario Mancinifirstname.lastname@example.org|
|Contact: Alice Andreassiemail@example.com|
|Study Director:||Mario Mancini||AO San Paolo|