Exploring the effect of the supplement AB070597 in humans with declining kidney function
| ISRCTN | ISRCTN44802329 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44802329 |
| Secondary identifying numbers | AB070597-5H |
- Submission date
- 22/07/2020
- Registration date
- 25/08/2020
- Last edited
- 04/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
4848 Olive Hill Road (28 Rolling View)
Fallbrook
92028
United States of America
 ORCID ID |
0000-0003-2245-8509 |
|---|---|
| Phone | +1 7607232316 |
| photoresearch@sbcglobal.net |
Study information
| Study design | Single-center open-ended longitudinal non-randomized, non-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Dr. James Archer (photoresearch@sbcglobal.net) to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2016 |
| Completion date | 30/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 5 |
| Total final enrolment | 5 |
| Key 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 |
| Key exclusion criteria | 1. Concurrent or suspected comorbidities unrelated to CKD 2. Diabetic |
| Date of first enrolment | 30/11/2016 |
| Date of final enrolment | 30/11/2017 |
Locations
Countries of recruitment
- United States of America
Study participating centres
Ste. 102 W
Palm Springs
California
92262
United States of America
Pomona
California
91767
United States of America
Torrance
California
90505
United States of America
Downey
California
90241
United States of America
West Hills
California
91304
United States of America
Sponsor information
Industry
18 Kendall Drive
Chapel Hill
North Carolina
27517
United States of America
| Phone | +1 (919) 321-9017 |
|---|---|
| info@whitsellinnovations.com | |
| Website | https://www.whitsellinnovations.com/ |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/11/2020 | 04/12/2020 | Yes | No |
Editorial Notes
04/12/2020: Publication reference added.
24/08/2020: Trial’s existence confirmed by Pearl IRB.
