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

NCT ID: NCT05348304

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-28

Study Completion Date

2022-10-12

Brief Summary

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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

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Conditions

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Metabolism Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Hypocaloric diet

Group Type NO_INTERVENTION

No interventions assigned to this group

EUDIAMET

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

Group Type EXPERIMENTAL

EUDIAMET

Intervention Type DIETARY_SUPPLEMENT

A combination of myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc

Interventions

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EUDIAMET

A combination of myo-inositol and D-chiro-inositol in the 40:1 ratio, Gymnema sylvestre, alpha-lactalbumin and zinc

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabrina Basciani

Role: PRINCIPAL_INVESTIGATOR

University of Roma La Sapienza

Locations

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Sapienza University of Rome

Rome, RM, Italy

Site Status

Countries

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Italy

Other Identifiers

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EUDIA_22

Identifier Type: -

Identifier Source: org_study_id

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