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

NCT02017405 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-09-19

Study results available
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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.

Conditions

  • Healthy

Interventions

OTHER

Serum-derived bovine immunoglobulin protein isolate (SBI)

Serum-derived bovine immunoglobulin protein isolate is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. Serum-derived bovine immunoglobulin protein isolate does not contain any milk products such as lactose, casein, or whey. Serum-derived bovine immunoglobulin protein isolate is gluten-free, dye-free, and soy-free. Serum-derived bovine immunoglobulin protein isolate is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.

OTHER

Matching Placebo

Sponsors & Collaborators

  • Entera Health, Inc

    lead INDUSTRY

Principal Investigators

  • Eric Weaver, PHD · Entera Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-03-31
Completion
2014-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02017405 on ClinicalTrials.gov