Plain English Summary
Background and study aims
Creatinine is a chemical waste product that's produced as a result of muscle movement and to a smaller extent by eating meat. Healthy kidneys filter creatinine and other waste products from your blood. The filtered waste products leave your body in your urine. In patients with kidney disease, as the disease progresses, the level of creatinine in the blood rises.
Glomerular filtration rate is another way to determine the extent of kidney disease and test the level of kidney function.
Based on a previous literature review, it was thought that supplementation with certain amino acids may have a role in improving renal (kidney) function as they have been shown to decrease blood-serum creatinine concentration and increase the glomerular filtration rate.
The trial aims to find whether oral supplementation with a specific amino acid/peptide complex will stabilize or improve the estimated glomerular filtration rate in humans with declining kidney function and if there is rationale for conducting a future randomized controlled trial with larger sample size.
Who can participate?
Non-diabetic white males aged 63 to 80 years under concurrent medical care in the United States, with chronic kidney disease (CKD) or an increased fall in kidney function over the previous 24 months.
What does the study involve?
Participants will take the supplement AB070597 (via mouth) daily for 10 months. They will give blood samples monthly during this period.
What are the possible benefits and risks of participating?
AB070597 supplementation may stabilize or improve renal function.
There are no known risks from taking dietary supplement AB070597.
Risks from blood collection include potential pain from the needle stick, and/or bruising.
Where is the study run from?
Quest Diagnostics (USA)
When is the study starting and how long is it expected to run for?
From April 2016 to May 2017
Who is funding the study?
John T Fulton Trust (USA)
Who is the main contact?
Dr James Archer
photoresearch@sbcglobal.net
Trial website
Contact information
Type
Scientific
Primary contact
Dr James Archer
ORCID ID
http://orcid.org/0000-0003-2245-8509
Contact details
4848 Olive Hill Road (28 Rolling View)
Fallbrook
92028
United States of America
+1 7607232316
photoresearch@sbcglobal.net
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
AB070597-5H
Study information
Scientific title
Exploratory-data and statistical analyses of AB070597, an amino acid and peptide complex, on blood-serum creatinine concentration and estimated glomerular filtration rate: a non-randomized pilot trial of five humans with declining renal-function
Acronym
Study hypothesis
Oral supplementation with a specific amino acid/peptide complex will stabilize or improve the estimated glomerular filtration rate in humans with chronologically declining renal function
Ethics approval
Approved 10/18/2016, Pearl IRB (29 E McCarty Street, Suite 100, Indianapolis, IN 46225 USA; +1 317-602-6104; gparker@pearlpathways.com), ref: 16-BIOS-101
Study design
Single-center open-ended longitudinal non-randomized, non-controlled trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Dr. James Archer (photoresearch@sbcglobal.net) to request a patient information sheet
Condition
Declining renal function in chronic kidney disease
Intervention
The intervention is oral administration of a daily dose of a specific amino acid/peptide complex. All participants are asked to follow the dosing schedule of six 1000 mg capsules, taken twice daily. Each capsule contains: 83 mg L-arginine, 167 mg glycine, 167 mg L-glutamine, 83 mg L-histidine, 167 mg L-aspartic acid, 167 mg L-glutamic acid, 167 mg L-carnosine.
Treatment continued for 12 consecutive months, with blood-serum creatinine concentration measured at 1-month intervals.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
1. Estimated glomerular filtration rate (eGFR) calculated from participant age and blood-serum creatinine concentration at baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months
2. Individual eGFR median-rate-of-change per unit time compared to eGFR medium-rate-of-change per unit time of 2870 chronic kidney disease participants in a study by Tsai CW, et al. (2017) using non-parametric one-sample Wilcoxon signed-rank test
Secondary outcome measures
1. Estimated glomerular filtration rate measured by blood-serum creatinine and age at baseline, 12, 34, and 36 weeks
Overall trial start date
01/11/2016
Overall trial end date
30/11/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 63 to 80 years
2. White
3. Male
4. Under concurrent medical care in the United States
5. Chronic kidney disease (CKD) or an estimated glomerular filtration rate (eGFR) decline rate of ≥4 ml/min/1.73 m² over the previous 24 months
6. History of increasing blood-serum creatinine from CKD or as a consequence of aging
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
5
Total final enrolment
5
Participant exclusion criteria
1. Concurrent or suspected comorbidities unrelated to CKD
2. Diabetic
Recruitment start date
30/11/2016
Recruitment end date
30/11/2017
Locations
Countries of recruitment
United States of America
Trial participating centre
Quest Diagnostics
555 E. Tachevah Dr.
Ste. 102 W
Palm Springs
California
92262
United States of America
Trial participating centre
Davita Pomona Dialysis
2111 N. Garey Ave.
Pomona
California
91767
United States of America
Trial participating centre
Quest Diagnostics
23441 Madison Street, Suite 300
Torrance
California
90505
United States of America
Trial participating centre
Quest Diagnostics
11525 Brookshire Avenue, Suite 401
Downey
California
90241
United States of America
Trial participating centre
Quest Diagnostics
8401 Fallbrook Ave.
West Hills
California
91304
United States of America
Sponsor information
Organisation
Whitsell Innovations
Sponsor details
18 Kendall Drive
Chapel Hill
North Carolina
27517
United States of America
+1 (919) 321-9017
info@whitsellinnovations.com
Sponsor type
Industry
Website
Funders
Funder type
Charity
Funder name
John T Fulton Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analyzed during the current study are/will be available to reasonable requests from the Applied Research Laboratory. Contact Dr. James Archer at photoresearch@sbcglobal.net.
Intention to publish date
01/11/2020
Participant level data
Available on request
Basic results (scientific)
Publication list