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

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
amino acid-based blend
Sponsored by
Pekarovics, Susan, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Private Medical Practics of Susan Pekarovics, MDRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Amino acid-based blend

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2020
Last Updated
August 9, 2020
Sponsor
Pekarovics, Susan, MD
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1. Study Identification

Unique Protocol Identification Number
NCT04510181
Brief Title
Effect of an Amino-Acid-Based Blend on Human Growth Hormone (hGH) and Fibromyalgia (FM) Symptoms
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pekarovics, Susan, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Amino acid-based blend
Arm Type
Experimental
Arm Description
The amino acid-based blend will be administered PO daily for the study duration
Intervention Type
Dietary Supplement
Intervention Name(s)
amino acid-based blend
Intervention Description
blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia
Primary Outcome Measure Information:
Title
Change in IGF-1
Description
change from baseline in IGF-1, a surrogate marker of hGH
Time Frame
24 weeks, 52 weeks
Secondary Outcome Measure Information:
Title
Fibromyalgia symptoms
Description
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)
Time Frame
24 weeks, 52 weeks
Title
Stress symptoms
Description
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)
Time Frame
24 weeks, 52 weeks
Title
Insulin-like growth factor binding protein-3 (IGFBP-3), an indicator of IGF-1 bioavailability
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
body weight (kg)
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
body mass index (BMI)
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
Blood pressure (systolic and diastolic)
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
HbA1c
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
Fasting total cholesterol
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
Fasting HDL cholesterol
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
Fasting LDL cholesterol
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
Fasting triglycerides
Description
Change from baseline
Time Frame
24 weeks, 52 weeks
Title
Fasting glucose
Description
Change from baseline
Time Frame
24 weeks, 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kati Kareki
Phone
323-951-4916
Email
kati.kereki@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Pekarovics, MD
Organizational Affiliation
Pekarovics, Susan, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Medical Practics of Susan Pekarovics, MD
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kati Kareki
Phone
323-951-4916
Email
kati.kereki@gmail.com
First Name & Middle Initial & Last Name & Degree
Susan Pekarovics, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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