Efficacy and Safety of D-chiro-inositol in Obese Patients

Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05348941

Enrollment

Registered

2022-04-27

Start date

2022-06-28

Completion date

2023-11-01

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

Brief summary

The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet

Detailed description

Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides. 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.

Interventions

DIETARY_SUPPLEMENTTECADRIOL

Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Women between 25 and 40 years old * Diagnosis of insulin resistance (HOMA ≥2.5) * 26≤ BMI ≤32

Exclusion criteria

* Subjects with no indication for treatment * Pregnancy and breastfeeding * Treatment with drugs or supplements that interfere with the mechanism of action of insulin

Design outcomes

Primary

Measure	Time frame	Description
HOMA index	Three time points: change in HOMA index from the baseline to 2 and 4 months	Reduction of HOMA index

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026