NCT05348304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2022

Completed
Last Updated

October 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

April 21, 2022

Last Update Submit

October 12, 2022

Conditions

Metabolism Disorder

Outcome Measures

Primary Outcomes (1)

  • Insulinemia

    Reduction of systemic insulin levels

    Three time points: change in insulin levels from the baseline to three and six months

Study Arms (2)

Control

NO INTERVENTION

Hypocaloric diet

EUDIAMET

EXPERIMENTAL

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

Interventions

EUDIAMETDIETARY_SUPPLEMENT

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

EUDIAMET

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 30 and 35
  • Basal Glycemia between 100 and 125 mg/dl

You may not qualify if:

  • Diabetes diagnosis
  • Use of food supplements containing inositols, gymnema, alpha-lactalbumin and zinc
  • Intolerance to inositols, gymnema, alpha-lactalbumin and zinc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University of Rome

Rome, RM, 00161, Italy

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Sabrina Basciani

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 27, 2022

Study Start

June 28, 2022

Primary Completion

September 26, 2022

Study Completion

October 12, 2022

Last Updated

October 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)