A Randomized Placebo Controlled Trial Assessing the Efficacy of Levagen+ for Treating Symptoms of Diabetic Peripheral Neuropathy

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN. Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Adults aged 18-75 years.

• Using prescribed glucose-lowering medications, including oral medications (stable dose for 3 months or more) and/or insulin for diabetes (type 1 or 2).

• Scoring12 or more on the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).

• Able to provide informed consent.

• Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period.

• Agree to not participate in another clinical trial during the study period.

• Able to attend an ACL collection centre.

Locations
Other Locations
Australia
RDC Clinical
RECRUITING
Fortitude Valley
Contact Information
Primary
Amanda Rao
research@rdcglobal.com.au
+61(0)731024486
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 80
Treatments
Experimental: Levagen+
Take 1 capsule twice daily with water after food. Each capsule will contain:~A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA.
Placebo_comparator: Placebo
Take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\].
Sponsors
Collaborators: Gencor Pacific Limited
Leads: RDC Clinical Pty Ltd

This content was sourced from clinicaltrials.gov