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

NCT04510181 | Unknown

• 1 other identifier: SePe-03-2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Change in IGF-1

  change from baseline in IGF-1, a surrogate marker of hGH

  24 weeks, 52 weeks

Secondary Outcomes (12)

• Fibromyalgia symptoms

  24 weeks, 52 weeks

• Stress symptoms

  24 weeks, 52 weeks

• Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability

  24 weeks, 52 weeks

• body weight (kg)

  24 weeks, 52 weeks

• body mass index (BMI)

  24 weeks, 52 weeks

Study Arms (1)

Amino acid-based blend

EXPERIMENTAL

The amino acid-based blend will be administered PO daily for the study duration

Dietary Supplement: amino acid-based blend

Interventions

amino acid-based blend DIETARY_SUPPLEMENT

blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia

Amino acid-based blend

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pekarovics, Susan, MD: lead

Study Sites (1)

Private Medical Practics of Susan Pekarovics, MD

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Susan Pekarovics, MD

  Pekarovics, Susan, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kati Kareki

CONTACT

323-951-4916; kati.kereki@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 12, 2020
• Study Start: August 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication
• Access Criteria: Upon appropriate data request by other scientists

Locations

US (1)