EUDIA_22: Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.
Sponsor
Lo.Li.Pharma s.r.l (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05348304
Collaborator
(none)
30
1
2
6.1
4.9
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official 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.
Actual Study Start Date
:
Jun 28, 2022
Anticipated Primary Completion Date
:
Oct 31, 2022
Anticipated Study Completion Date
:
Dec 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Hypocaloric diet |
|
| Experimental: EUDIAMET Hypocaloric diet plus a supplementation with myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc |
Dietary Supplement: EUDIAMET
A combination of myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc
|
Outcome Measures
Primary Outcome Measures
- Insulinemia [Three time points: change in insulin levels from the baseline to three and six months]
Reduction of systemic insulin levels
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sapienza University of Rome | Rome | RM | Italy | 00161 |
Sponsors and Collaborators
- Lo.Li.Pharma s.r.l
Investigators
- Principal Investigator: Sabrina Basciani, Sapienza University of Rome
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier:
NCT05348304
Other Study ID Numbers:
- EUDIA_22
First Posted:
Apr 27, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: