Combination of D-chiro-inositol With Ketogenic Diet

NCT05348967 | Withdrawn

• 1 other identifier: DCI_KETO22
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate whether the combination of a product based on D-chiro-inositol and the ketogenic diet can improve the metabolic/endocrine picture of overweight/obese women with PCOS, with insulin resistance, in a shorter time than the ketogenic diet alone

Conditions

Polycystic Ovary Syndrome

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

Ketogenic diet

TECADRIOL

EXPERIMENTAL

Ketogenic diet plus a food supplement containing an association of D-chiro-inositol and alpha-lactalbumin

Dietary Supplement: TECADRIOL

Interventions

TECADRIOL DIETARY_SUPPLEMENT

Food supplement with D-chiro-inositol and alpha-lactalbumin

TECADRIOL

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with age between 25 and 40 years
• Diagnosis of Polycystic Ovary Syndrome (PCOS)
• Diagnosis of insulin-resistance (HOMA ≥2.5)
• ≤ BMI ≤32

You may not qualify if:

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

Sponsors & Collaborators

• Lo.Li.Pharma s.r.l: lead

Study Sites (1)

Sapienza University of Rome

Rome, Italy

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System 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: October 14, 2022
• Primary Completion: November 1, 2023
• 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)