Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Dietary Supplement: amino acid-based blend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a clinical diagnosis of FM for at least 10 years, poorly controlled FM symptom, and receiving standard of care treatment at the Private Medical Practice of Susan Pekarovics, MD Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50th percentile for age-appropriate levels) Female participants of childbearing potential will agree to avoid pregnancy during the study. Capable of giving signed informed consent Exclusion Criteria: Human growth hormone deficiency (GHD) Individuals with a total score of ≥15 (indicating the presence of moderately severe major depression) or a score of >0 on Item 9 (suicidal ideation) on the Patient Health Questionnaire-9 (PHQ-9) Pregnant women or women who wish to become pregnant History of substance abuse Previous treatment with recombinant human growth hormone (rhGH) Individuals belonging to the following vulnerable populations: people with disabilities, people who cannot read, educationally disadvantaged, individuals with a serious or life threatening illness, prisoners, non-English speakers, economically disadvantaged individuals, employees of the study sponsor/site.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amino acid-based blend<br>The amino acid-based blend will be administered PO daily for the study duration | Dietary Supplement: amino acid-based blend<br>* blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IGF-1 | change from baseline in IGF-1, a surrogate marker of hGH | 24 weeks, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 24 weeks, 52 weeks | 
| Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability | Change from baseline | 24 weeks, 52 weeks | 
| body weight (kg) | Change from baseline | 24 weeks, 52 weeks | 
| body mass index (BMI) | Change from baseline | 24 weeks, 52 weeks | 
| Blood pressure (systolic and diastolic) | Change from baseline | 24 weeks, 52 weeks | 
| HbA1c | Change from baseline | 24 weeks, 52 weeks | 
| Fasting total cholesterol | Change from baseline | 24 weeks, 52 weeks | 
| Fasting HDL cholesterol | Change from baseline | 24 weeks, 52 weeks | 
| Fasting LDL cholesterol | Change from baseline | 24 weeks, 52 weeks | 
| Fasting triglycerides | Change from baseline | 24 weeks, 52 weeks | 
| Fasting glucose | Change from baseline | 24 weeks, 52 weeks |