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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03920787

Recruitment Status Recruiting

First Posted April 19, 2019

Last update posted April 22, 2019

Study Description

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.

  • Condition or Disease:Insulin Resistance
  • Intervention/Treatment: Dietary Supplement: Inofolic Combi
    Other: Placebo
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 23 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Effects of Inositol Supplementation in Children With Excessive Body Weight and Insulin Resistance
  • Actual Study Start Date: March 2018
  • Estimated Primary Completion Date: March 2020
  • Estimated Study Completion Date: April 2020
Arms and interventions
Arm Intervention/treatment
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
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
Other: Placebo
2 capsules every day for 1 month
Outcome Measures
  • Primary Outcome Measures: 1. Basal Insulin [ Time Frame: 1 month ]
    Evaluation of the efficacy of inositol in reducing basal insulin
  • Secondary Outcome Measures: 1. Body weight [ Time Frame: 1 month ]
    Evaluation of the efficacy of inositol in reducing body weight
Eligibility Criteria
  • Ages Eligible for Study: 8 to 18 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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

Contacts and Locations
Contacts

Contact: Mario Mancini 00393331009479 mancinis178@msn.com

Contact: Alice Andreassi 00393401799869 aliceandreassi2@gmail.com

Locations

Italy, Mi
AO San Paolo
Milan

Sponsors and Collaborators

Alice Andreassi

Lo.Li.Pharma s.r.l

Azienda Ospedaliera San Paolo

Investigators

Study Director: Mario Mancini AO San Paolo

More Information