Efficacy and Safety of D-chiro-inositol in Obese Patients
NCT ID: NCT05348941
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2022-06-28
2023-11-01
Brief Summary
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Detailed Description
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However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects.
It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome.
Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
Hypocaloric balanced diet
No interventions assigned to this group
TECADRIOL
Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin
TECADRIOL
Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin
Interventions
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TECADRIOL
Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of insulin resistance (HOMA ≥2.5)
* 26≤ BMI ≤32
Exclusion Criteria
* Pregnancy and breastfeeding
* Treatment with drugs or supplements that interfere with the mechanism of action of insulin
25 Years
40 Years
FEMALE
No
Sponsors
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Lo.Li.Pharma s.r.l
INDUSTRY
Responsible Party
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Locations
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Sapienza University of Rome
Roma, RM, Italy
Countries
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Other Identifiers
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DCI_DIET22
Identifier Type: -
Identifier Source: org_study_id
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