The purpose of the study is to investigate the effect of the amino acid-based blend on growth hormone levels (measured by IGF-1) and clinical symptoms in individuals with treatment-resistant FM and low-normal hGH.
Low hGH levels have been observed in approximately 1/3 of individuals with FM. Low hGH levels are hypothesized to contribute to inadequate treatment outcomes in many individuals with FM and several studies have demonstrated symptom improvement in individuals with FM and low hGH who received rhGH therapy. The amino acid-based blend represents a novel mechanism for increasing endogenous hGH production. It has been shown to produce an increase in endogenous hGH levels in healthy individuals by attenuating the inhibitory effect of somatostatin on hGH release. The amino acid-based blend may be a safe and effective treatment for FM in individuals with poorly controlled FM and low-normal hGH. This study will investigate the effect of taking the amino acid blend on IGF-1 levels (a surrogate marker of the body's growth hormone levels), fibromyalgia symptoms, stress symptoms, body weight, and other cardiometabolic biomarkers in individuals with treatment-resistant FM and low-normal hGH. After being informed about the study and potential risks, all eligible participants giving written informed consent will administer the amino acid-based blend daily. Standard care for fibromyalgia will continue.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia
Private Medical Practics of Susan Pekarovics, MD
Los Angeles, California, United States
RECRUITINGChange in IGF-1
change from baseline in IGF-1, a surrogate marker of hGH
Time frame: 24 weeks, 52 weeks
Fibromyalgia symptoms
Change from baseline in score on the Revised Fibromyalgia Impact Questionnaire (FIQR, a 21-item self-report measure that estimates the severity and impact of FM. Score ranges from 0-100 with higher scores indicating greater severity/impact of FM)
Time frame: 24 weeks, 52 weeks
Stress symptoms
Change from baseline in score of the Perceived Stress Scale (PSS, a 10-item self-report measure that assesses the perception of stress. Total score ranges from 0-40 with higher scores indicating greater perceived stress)
Time frame: 24 weeks, 52 weeks
Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability
Change from baseline
Time frame: 24 weeks, 52 weeks
body weight (kg)
Change from baseline
Time frame: 24 weeks, 52 weeks
body mass index (BMI)
Change from baseline
Time frame: 24 weeks, 52 weeks
Blood pressure (systolic and diastolic)
Change from baseline
Time frame: 24 weeks, 52 weeks
HbA1c
Change from baseline
Time frame: 24 weeks, 52 weeks
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Fasting total cholesterol
Change from baseline
Time frame: 24 weeks, 52 weeks
Fasting HDL cholesterol
Change from baseline
Time frame: 24 weeks, 52 weeks
Fasting LDL cholesterol
Change from baseline
Time frame: 24 weeks, 52 weeks
Fasting triglycerides
Change from baseline
Time frame: 24 weeks, 52 weeks
Fasting glucose
Change from baseline
Time frame: 24 weeks, 52 weeks