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

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.

Study Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Dietary supplement: amino acid-based blend

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Private Medical Practics of Susan Pekarovics, MD
      • Contact: Kati Kareki; Phone Number: 323-951-4916; Email: kati.kereki@gmail.com
      • Principal Investigator: Susan Pekarovics, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amino acid-based blend; The amino acid-based blend will be administered PO daily for the study duration	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pekarovics, Susan, MD
• Investigators: Principal Investigator: Susan Pekarovics, MD, Pekarovics, Susan, MD

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: SePe-03-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
• IPD Sharing Time Frame: Beginning 6 months after publication
• IPD Sharing Access Criteria: Upon appropriate data request by other scientists
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No