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 : Unknown
Verified April 2019 by Alice Andreassi, Azienda Ospedaliera San Paolo.
Recruitment status was: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|