NCT05348941

Brief Summary

The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2022

Completed
5 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 27, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

April 22, 2022

Last Update Submit

May 29, 2025

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • HOMA index

    Reduction of HOMA index

    Three time points: change in HOMA index from the baseline to 2 and 4 months

Study Arms (2)

Control

NO INTERVENTION

Hypocaloric balanced diet

TECADRIOL

EXPERIMENTAL

Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin

Dietary Supplement: TECADRIOL

Interventions

TECADRIOLDIETARY_SUPPLEMENT

Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin

TECADRIOL

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 25 and 40 years old
  • Diagnosis of insulin resistance (HOMA ≥2.5)
  • ≤ BMI ≤32

You may not qualify if:

  • Subjects with no indication for treatment
  • Pregnancy and breastfeeding
  • Treatment with drugs or supplements that interfere with the mechanism of action of insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University of Rome

Roma, RM, 00161, Italy

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

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

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 27, 2022

Study Start

June 28, 2022

Primary Completion

September 27, 2022

Study Completion

November 1, 2023

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)