Fibromyalgia Clinical Trial
Official title:
Effect of an Orally Administered Amino Acid-Based Blend on Human Growth Hormone (hGH) Levels and Fibromyalgia (FM) Symptoms: A Prospective, Open-Label, Single-Arm, Observational 24-Week Study in Adults With Poorly Controlled FM and Low hGH
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.
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