Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Neuropathic Pain.

NCT07377409 | Not Yet Recruiting

• 1 other identifier: 1812/28082025
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the potential benefit of an oral nutritional supplement based on CRONILIEF™ (Palmitoylethanolamide Phospholipids) in diabetic subjects with neuropathic pain, compared to a placebo.

Conditions

Neuropathic Pain Management; Diabetic Neuropathies, Painful; Palmitoylethanolamide

Outcome Measures

Primary Outcomes (1)

• Evaluate specific symptoms of neuropathic pain in diabetic subjects

  Evaluate the effectiveness of Cronilief™ supplementation versus placebo, in combination with standard therapy, in improving specific symptoms of neuropathic pain in diabetic subjects after 8 weeks of supplementation, using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire as an assessment tool. The LANSS score ranges from 0 to 24, with higher scores indicating a greater neuropathic pain component (worse outcome). A score ≥12 is indicative of neuropathic pain.

  Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

Secondary Outcomes (3)

• Evaluate sleep quality

  Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

• Evaluate emotional states

  Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Baseline (T0), 4 week (T1), 8 week (T2) and one month after the end of integration

Study Arms (2)

Group A: Cronilief™ supplementation

EXPERIMENTAL

Cronilief™ (300 mg) supplementation

Dietary Supplement: Cronilief™ (300 mg)

Group B: Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Cronilief™ (300 mg) DIETARY_SUPPLEMENT

* Week 1: Cronilief™ (300 mg), 2 tablets per day, single administration * Weeks 2-8: Cronilief™ (300 mg), 1 tablet per day

Group A: Cronilief™ supplementation

Placebo DIETARY_SUPPLEMENT

* Week 1: Placebo, 2 tablets per day, single administration * Weeks 2-8: Placebo, 1 tablet per day.

Group B: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Satisfactory metabolic compensation;
• Presence of moderate symptoms of painful diabetic neuropathy as assessed by the LANSS questionnaire (score ≥12);
• Taking antidiabetic drugs except insulin;
• Subjects willing and able to comply with scheduled study visits, the treatment plan, and all procedures outlined in the study.

You may not qualify if:

• Previous intolerance to a component of the nutraceuticals tested;
• Individuals with type I diabetes;
• Uncontrolled diabetes, severe cardiovascular and cerebrovascular diseases;
• Severe neuropathic symptoms as indicated by the LANSS score;
• Individuals undergoing insulin treatment;
• Peripheral neuropathy due to diseases other than diabetes mellitus;
• History of malignant neoplasm in the 5 years prior to enrolment in the study;
• Serious neurological, psychological or psychiatric disorders;
• Clinical signs or history of significant impairment of hepatic or renal function, peptic ulcer or coagulation disorders;
• Any clinically relevant or unstable disease (e.g., active malignancies, immune system disorders) whose sequelae or treatments could contraindicate participation in the study or interfere with the study's evaluation parameters, in the investigator's judgement; Any disease that could significantly affect the study's outcome, including, but not limited to, chronic medical conditions, psychological disorders, or substance abuse;
• Alcohol or drug abuse;
• Women of childbearing age who do not use established contraceptive methods;
• Pregnancy and breastfeeding.

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 29, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-01