Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Fibromyalgia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
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 the...
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.
Tracking Information
- NCT #
- NCT04510181
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Susan Pekarovics, MD Pekarovics, Susan, MD