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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3
non-essential dietary amino acid
University of Kentucky Center for Clinical and Translational Science
Lexington, Kentucky, United States
Pain score
McGill short form Visual Analogue Scale (VAS scale) 1 normal 2-10 pain level
Time frame: 3 months
Well Being
Normal: 0 of 30 days with major impairment; 30 of 30 days feeling very healthy and full of energy
Time frame: 3 months
Generalized anxiety disorder 7-item (GAD-7) Scoring
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
Time frame: 3 months
Patient Depression Questionnaire Scoring
5-\<10 Mild Depression; 10-\<15 Moderate Depression; 15-\<20 Moderately Severe Depression; \>20 Severe Depression
Time frame: 3 months
Inflammatory Markers
TBARS: in fasted (8 hrs) 4.7±0.2 μmol/l blood serum; TGFbeta1: 20-50 pg/ml; PDGF: 20-30 pg/ml
Time frame: 3 months
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