Absorption and safety of serum-derived bovine immunoglobulin/protein isolate in healthy adults
| Autor: | Gerald L. Klein, John Hinkle, David W Mathews, Timothy P Bradshaw, Bryon W. Petschow, Christopher J. Detzel, Eric M. Weaver, Audrey L. Shaw |
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| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
Clinical and Experimental Gastroenterology biology business.industry intestinal absorption Gastroenterology Area under the curve Pharmacology Placebo Intestinal absorption Immunoglobulin G 03 medical and health sciences 030104 developmental biology Clinical Trial Report Oral administration plasma amino acids biology.protein Ingestion Medicine bovine immunoglobulin Antibody business Serum-derived bovine immunoglobulin/protein isolate |
| Zdroj: | Clinical and Experimental Gastroenterology |
| ISSN: | 1178-7023 |
| Popis: | Audrey L Shaw,1 David W Mathews,1 John E Hinkle,2 Bryon W Petschow,1 Eric M Weaver,3 Christopher J Detzel,1 Gerald L Klein,4 Timothy P Bradshaw1 1Clinical Development, Entera Health, Inc., 2Life Sciences Consulting and Analytics, EarlyPhase Sciences, Inc., Cary, 3Executive Management, Prairie Pharms, LLC, Nora Springs, 4Executive Management, MedSurgPI, LLC, Raleigh, NC, USA Purpose: Previous studies have shown that oral administration of bovine immunoglobulin protein preparations is safe and provides nutritional and intestinal health benefits. The purpose of this study was to evaluate the plasma amino acid response following a single dose of serum-derived bovine immunoglobulin/protein isolate (SBI) and whether bovine immunoglobulin G (IgG) is present in stool or in blood following multiple doses of SBI in healthy volunteers.Methods: A total of 42 healthy adults were administered a single dose of placebo or SBI at one of three doses (5 g, 10 g, or 20 g) in blinded fashion and then continued on SBI (2.5 g, 5 g, or 10 g) twice daily (BID) for an additional 2weeks. Serial blood samples were collected for amino acid analysis following a single dose of placebo or SBI. Stool and blood samples were collected to assess bovine IgG levels.Results: The area under the curve from time 0minute to 180 minutes for essential and total amino acids as well as tryptophan increased following ingestion of 5g, 10g, or 20g of SBI, with a significant difference between placebo and all doses of SBI (p |
| Databáze: | OpenAIRE |
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