Metabolism Disorder Clinical Trial
— EUDIA_22Official title:
Hypoglycemic Effects of a Dietary Supplement That Combines the Properties of Myo-inositol and D-chiro-inositol With Gymnema Silvestre, Alpha-lactalbumin and Zinc.
| NCT number | NCT05348304 |
| Other study ID # | EUDIA_22 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | June 28, 2022 |
| Est. completion date | October 12, 2022 |
| Verified date | June 2022 |
| Source | Lo.Li.Pharma s.r.l |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study is aimed at evaluating the hypoglycemic effects of a dietary supplement that associates the properties of two inositols (myo-inositol and D-chiro-inositol) in the ratio 40:1 to Gymnema sylvestre, alpha-lactalbumin and zinc.
| Status | Completed |
| Enrollment | 37 |
| Est. completion date | October 12, 2022 |
| Est. primary completion date | September 26, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - BMI between 30 and 35 - Basal Glycemia between 100 and 125 mg/dl Exclusion Criteria: - Diabetes diagnosis - Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc - Intolerance to inositols, gymnema, alpha-lactalbumin and zinc |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Sapienza University of Rome | Rome | RM |
| Lead Sponsor | Collaborator |
|---|---|
| Lo.Li.Pharma s.r.l |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Insulinemia | Reduction of systemic insulin levels | Three time points: change in insulin levels from the baseline to three and six months |
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