Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy

Official title

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

Overview

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.

Interventions

• Dietary supplement Levagen+
  Participants will 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
• Other Placebo
  Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\]

Primary outcome measures

• Change from baseline to the end of the study period in overall severity of neuropathic pain [Time frame: Baseline to week 12]

Secondary outcome measures (12)

• Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Safety via Adverse Event reporting [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Safety Markers (FBC) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Safety Markers (E/LFT) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Safety (Vitals - BP) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Safety (Vitals - heart rate) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Medical Outcomes Study - Sleep Scale (MOS-Sleep) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Depression Anxiety and Stress Scale (DASS-21) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Glycaemic control (HbA1c) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Glycaemic control (fasting blood glucose) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Anthropometry (weight) [Time frame: Baseline to week 12]
• Change from baseline to the end of the study period in Anthropometry (height) [Time frame: Baseline to week 12]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Peripheral neuropathy due to causes other than diabetes mellitus (e.g. nutritional deficiencies; hereditary sensory neuropathy; paraneoplastic diseases; advanced liver disease; kidney disease; hypothyroidism; prolonged phenytoin, warfarin or immunosuppressive drug use; active infection \[HIV, Lyme disease, Epstein-Barr virus, Hepatitis C, Shingles, Leprosy\]; autoimmune disease \[Sjogren syndrome, Lupus, Rheumatoid arthritis, Guillain-Barre syndrome\]; trauma / injury; toxins \[heavy metals, chemicals\]; antibiotics; or inflammatory conditions \[vasculitis\]).
• Serious illness e.g., paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, or heart conditions, or peripheral vascular disease
• Unstable illness e.g., diabetes and thyroid gland dysfunction, hypercholesterolemia
• Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
• Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
• Herbal medicines for pain relief including, but not limited to, medicinal cannabis, willow bark (Salix alba), Boswellia (Boswellia serrata) or turmeric/curcumin (Curcuma longa).
• Active smokers, nicotine use or drug (prescription or illegal substances) abuse.
• Chronic past and/or current alcohol use (>14 alcoholic drinks per week)
• Females attempting to conceive, pregnant or lactating
• Allergic, sensitive or intolerant to any of the ingredients in active or placebo formula.
• Difficulty swallowing capsules.
• Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
• Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Australia · 1 center

• RDC Clinical — Fortitude Valley

Identifiers

NCT: NCT07028528 · NEULEV

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗