Hypoglycemic Effects of a Dietary Supplement With Inositols, Gymnema Silvestre, Alpha-lactalbumin and Zinc.

Not Applicable

Completed

• Conditions: Metabolism Disorder
• Interventions: Dietary Supplement: EUDIAMET

• Registration Number: NCT05348304
• Lead Sponsor: Lo.Li.Pharma s.r.l

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Status Verified: 2022-06
• Study Start: 2022-06-28
• Primary Completion: 2022-09-26
• Study Completion: 2022-10-12
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUDIAMET	EUDIAMET	Hypocaloric diet plus a supplementation with myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc

Primary Outcome Measures

Name	Time	Method
Insulinemia	Three time points: change in insulin levels from the baseline to three and six months	Reduction of systemic insulin levels

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Rome, RM, Italy