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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04510181
• Other study ID #: SePe-03-2020
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2020
• Source: Pekarovics, Susan, MD
• Contact: Kati Kareki
• Phone: 323-951-4916
• Email: kati.kereki[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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

2. Have low to normal levels of hGH (screening IGF-1 levels between the 15th and 50th percentile for age-appropriate levels)

3. Female participants of childbearing potential will agree to avoid pregnancy during the study.

4. Capable of giving signed informed consent

Exclusion Criteria:

1. Human growth hormone deficiency (GHD)

2. 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)

3. Pregnant women or women who wish to become pregnant

4. History of substance abuse

5. Previous treatment with recombinant human growth hormone (rhGH)

6. 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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Dietary Supplement:
• amino acid-based blend
blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia

Locations

Country	Name	City	State
United States	Private Medical Practics of Susan Pekarovics, MD	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Pekarovics, Susan, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IGF-1	change from baseline in IGF-1, a surrogate marker of hGH	24 weeks, 52 weeks
Secondary	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
Secondary	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
Secondary	Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability	Change from baseline	24 weeks, 52 weeks
Secondary	body weight (kg)	Change from baseline	24 weeks, 52 weeks
Secondary	body mass index (BMI)	Change from baseline	24 weeks, 52 weeks
Secondary	Blood pressure (systolic and diastolic)	Change from baseline	24 weeks, 52 weeks
Secondary	HbA1c	Change from baseline	24 weeks, 52 weeks
Secondary	Fasting total cholesterol	Change from baseline	24 weeks, 52 weeks
Secondary	Fasting HDL cholesterol	Change from baseline	24 weeks, 52 weeks
Secondary	Fasting LDL cholesterol	Change from baseline	24 weeks, 52 weeks
Secondary	Fasting triglycerides	Change from baseline	24 weeks, 52 weeks
Secondary	Fasting glucose	Change from baseline	24 weeks, 52 weeks