Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Hypocaloric balanced diet | |
| TECADRIOL | Experimental | Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TECADRIOL | Dietary Supplement | Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin |
|
| Measure | Description | Time Frame |
|---|---|---|
| HOMA index | Reduction of HOMA index | Three time points: change in HOMA index from the baseline to 2 and 4 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapienza University of Rome | Roma | RM | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40235665 | Derived | Basciani S, Nordio M, Spizzichini ML, Gnessi L. Unexpected effects of treating insulin-resistant obese women with high-dose D-chiro-inositol: opening Pandora's box. Front Endocrinol (Lausanne). 2025 Apr 1;16:1399308. doi: 10.3389/fendo.2025.1399308. eCollection 2025. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided