Effect of Acetyl-L-carnitine on Chronic Pancreatitis
- Conditions
- Chronic Pancreatitis
- Interventions
- Dietary Supplement: acetyl-L-carnitine 1000mg 2X per day for 3 months
- Registration Number
- NCT02538146
- Lead Sponsor
- Karin High
- Brief Summary
An open label pilot study will determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The ALC is given to all participants for 3 months, and assessments will occur at intake and after 3 months.
- Detailed Description
This is an open label pilot study to determine the effect of the amino acid nutritional supplement acetyl-L-carnitine (ALC) on chronic pancreatitis. ALC is an acetylated form of naturally occurring amino acid L-carnitine ((R)-3-Acetyloxy-4-trimethylammonio-butanoate) found in red meat and is readily commercially available. Supplementation with ALC may decrease pain and improve overall health based on our preclinical treatment studies in rats with high fat and alcohol induced pancreatitis. In rats, ALC reduces pain measures, improves glucose tolerance, decreases lipid peroxidation, and Ki67 cellular injury biomarker, and improves pancreatic histopathology. The measurable outcomes of this clinical study are patients' questionnaire scores for:
pain, quality of life, well-being, and serum pro-inflammatory mediator and oxidative stress levels in volunteers with chronic pancreatitis. The questionnaires are given at intake and at experiment end (3 months). Participants will receive ALC for 3 months. These findings will indirectly determine the effect of ALC on the function and inflammatory state of the pancreas. Currently, there is no specific therapy for chronic pancreatitis, and its pathophysiology is still poorly understood. It is known that chronic pancreatitis is caused by ongoing inflammation in the pancreas, yet, no pharmacological intervention exists that optimally addresses this. The broad actions of ALC as an antioxidant and anti-inflammatory agent as well as its ability to reduce side-effects of alcohol cessation make it a perfect compound to pursue for the treatment of pancreatitis.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
- Only patients with chronic pancreatitis are included.
- Patients with pancreatic pseudocysts, abscesses, pseudoaneurysms, pancreatitic fistulas, pancreatic adenocarcinoma,
- Females that are pregnant or lactating
- Children are excluded.
- Patients suffering from seizure or thyroid disorders are also excluded due to possible exaggeration of their symptoms from taking ALC according to manufacturer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment acetyl-L-carnitine 1000mg 2X per day for 3 months Acetyl-L-carnitine 1000mg 2X per day for 3 months
- Primary Outcome Measures
Name Time Method Pain score 3 months McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level
- Secondary Outcome Measures
Name Time Method Inflammatory Markers 3 months TBARS: in fasted (8 hrs) 4.7±0.2 μmol/l blood serum; TGFbeta1: 20-50 pg/ml; PDGF: 20-30 pg/ml
Well Being 3 months Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy
Generalized anxiety disorder 7-item (GAD-7) Scoring 3 months 5-\< 10 Mild Anxiety 10-\<15 Moderate Anxiety \>15 Severe Anxiety 5-\< 10 Mild Anxiety 10-\<15 Moderate Anxiety \>15 Severe Anxiety 5-\< 10 Mild Anxiety 10-\<15 Moderate Anxiety \>15 Severe Anxiety 5-\< 10 Mild Anxiety; 10-\<15 Moderate Anxiety; \>15 Severe Anxiety
Patient Depression Questionnaire Scoring 3 months 5-\<10 Mild Depression; 10-\<15 Moderate Depression; 15-\<20 Moderately Severe Depression; \>20 Severe Depression
Trial Locations
- Locations (1)
University of Kentucky Center for Clinical and Translational Science
🇺🇸Lexington, Kentucky, United States