N/A N=42 Randomized Triple-blind Other

Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT02017405 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Concentration of Total Plasma Amino Acids — 2730.87; 2988.94; 2964.19; 2869.14 umol/mL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Serum-derived bovine immunoglobulin protein isolate (SBI) (Other); Matching Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Entera Health, Inc
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Concentration of Total Plasma Amino Acids	2730.87; 2988.94; 2964.19; 2869.14; 2723.72; 2785.20	—
SECONDARY Number of Participants With Quantifiable Bovine IgG Plasma Concentration	0; 0; 0; 1; 0; 0	—
SECONDARY Bovine IgG Concentration in Stool	100.79; 160.20; 111.59	—

Summary

The purpose of this study is to determine the digestibility of serum-derived bovine immunoglobulin protein isolate in healthy adults. The information generated may help elucidate SBI's mechanism of action.

Eligibility Criteria

Inclusion Criteria

Body mass index of 18-32
Medically normal with no significant abnormal findings at screening

Exclusion Criteria

Allergy or intolerance to beef
Participated in another investigational study within 30 days
Seropostive for HIV, hepatitis B surface antigen, hepatitis C virus

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02017405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.