Unique Post‐Prandial Amino Acid Responses Following Oral Administration of Serum‐Derived Bovine Immunoglobulin
Authors: Weaver Eric M. , Petschow Bryon W. , Mathews David W. , Burnett Bruce , Shaw Audrey L. , Bradshaw Timothy P. , Hinkle John 
Published: November 2023

Background

It is well known that many patients with gastrointestinal (GI) and immune system dysfunction are often also nutritionally compromised. Earlier studies in animals and humans have demonstrated that oral administration of bovine immunoglobulins helps maintain gut barrier function and improve nutritional status. Serum‐derived bovine immunoglobulin/protein isolate (SBI) is a medical food comprised of over 50% IgG and is intended to provide a therapeutic dietary solution for the distinctive nutritional requirements unique to certain intestinal disorders. The amino acid composition of SBI reflects that of a high quality protein source being rich in essential amino acids such as leucine, lysine, and tryptophan. The amino acid availability of SBI with different levels of ingestion has not been reported. The major objective of this study was to determine in healthy adults the effects of increasing doses of SBI on post‐prandial amino acid concentrations in plasma.

Methods

On Day 1 of this randomized, placebo‐controlled, cross‐over study, overnight fasted subjects (n=42) were administered a single dose of placebo or SBI at a level of 5 g, 10 g or 20 g in a blinded fashion. On Day 2 overnight fasted subjects received a matching dose of the investigational product not received the previous day. All subjects received the assigned dose of SBI open‐label for an additional 2 weeks (2.5 g, 5.0 g, or 10 g BID) to assess safety. Serial blood samples were collected on Day 1 and 2 immediately before (time 0) and 15, 30, 45, 60, 90, 120 and 180 minutes after administration of placebo or SBI. Post‐prandial plasma amino acid response as measured by time to peak concentration and area under the curve (AUC). Plasma amino acid analysis was conducted by liquid chromatography‐electrospray‐tandem mass spectrometry (LC‐ESI‐MS/MS). Safety was assessed by physical examination, clinical laboratory testing and monitoring of adverse events.

Results

Ingestion of SBI led to significant increases in plasma total (TAA) and essential amino acids (EAA) by AUC in all SBI treatment groups when compared to the placebo group (P<0.05). Surprisingly, TAA and EAA peak concentrations occurred from 30–45 min for the lower doses of SBI (5 g and 10 g) and from 90–120 min for the SBI 20 g group. Also, plasma tryptophan levels remained above baseline through 180 minutes following the 20 g dose of SBI (P<0.01), but returned to baseline earlier in the 5 g and 10 g SBI groups. All AEs reported by subjects given SBI were viewed as mild or moderate in intensity and no serious AEs were reported.

Conclusions

Oral administration of SBI was found to be safe at levels as high as 20 g per day. SBI ingestion leads to increases in plasma total and essential amino acids levels with a unique delay in post‐prandial responses and sustained tryptophan responses at higher doses. The extended duration of the amino acid response, particularly tryptophan, following higher doses of SBI may provide unique nutritional benefits to immune or GI compromised patients.

Support or Funding Information

This research was funded solely by Entera Health, Inc.