NCT07263789

Brief Summary

The primary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing FPG compared to baseline and to recommended standard diet alone after 3 months

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 23, 2025

Last Update Submit

November 23, 2025

Conditions

Dysglycemia

Outcome Measures

Primary Outcomes (1)

  • Dysglicemia

    The primary objective is to evaluate the efficacy of Euglycem® plus recommended standard diet on reducing FPG compared to baseline and to recommended standard diet alone after 3 months of supplementation.

    3 months

Secondary Outcomes (3)

  • Insulin reistance

    3 months

  • Vitamin D3 levels

    3 months

  • Glycemic status

    3 months

Study Arms (2)

Euglycem

ACTIVE COMPARATOR

An association of banaba leaves extract and chromium picolinate

Dietary Supplement: Nutraceutical supplements

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Nutraceutical supplementsDIETARY_SUPPLEMENT

An association of banaba leaves extract and chromium picolinate (Euglycem®) will be administered

Euglycem
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI ≤30 kg/m2
  • subjects able to understand the informed consent and sign it before enrollment in the study
  • subjects willing to follow all study requirements and perform all study visits as well as collaborate with the investigator.

You may not qualify if:

  • ongoing treatment with drugs that can affect blood glucose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Policlinico San Matteo

Pavia, Lombardy, 27100, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Pavia, 27100, Italy

NOT YET RECRUITING

Central Study Contacts

Giuseppe Derosa, MD

CONTACT

+390382502614g.derosa@smatteo.pv.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Giuseppe Derosa

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 4, 2025

Study Start

April 8, 2025

Primary Completion

December 31, 2025

Study Completion

January 31, 2026

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)