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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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This study is evaluating the safety and absorption of serum-derived bovine immunoglobulin protein isolate (SBI) in healthy adults using 5, 10, and 20 g doses of SBI and placebo equivalents in a double blind crossover study and SBI affects over 14 days. Additionally, plasma amino acid response and IgG concentrations in both stool and plasma will be investigated.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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5g Serum-derived bovine immunoglobulin protein isolate (SBI)

Phase 1: Twelve subjects will receive either a 5.0 g total daily dose of SBI on Day 1 followed by 5.0 g Placebo on Day 2 or a 5.0 g total daily dose of Placebo on Day 1 followed by 5.0 g SBI on Day 2 during the double-blind, crossover phase.

Phase 2: 2.5g SBI will be taken two times a day for 14 days during the open-label phase.

Group Type OTHER

Serum-derived bovine immunoglobulin protein isolate (SBI)

Intervention Type OTHER

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.

10g Serum-derived bovine immunoglobulin protein isolate (SBI)

Phase 1: Twelve subjects will receive either a 10.0 g total daily dose of SBI on Day 1 followed by 10.0 g Placebo on Day 2 or a 10.0 g total daily dose of Placebo on Day 1 followed by 10.0 g SBI on Day 2 during the double-blind, crossover phase.

Phase 2: 5.0 g SBI will taken two times a day for 14 days during the open-label phase.

Group Type OTHER

Serum-derived bovine immunoglobulin protein isolate (SBI)

Intervention Type OTHER

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.

20g Serum-derived bovine immunoglobulin protein isolate (SBI)

Phase 1: Twelve subjects will receive either a 20.0 g total daily dose of SBI on Day 1 followed by 20.0 g Placebo on Day 2 or a 20.0 g total daily dose of Placebo on Day 1 followed by 20.0 g SBI on Day 2 during the double-blind, crossover phase.

Phase 2: 20.0 g SBI will be taken two times a day for 14 days during the open-label phase.

Group Type OTHER

Serum-derived bovine immunoglobulin protein isolate (SBI)

Intervention Type OTHER

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.

Matching Placebo

Placebo will be taken either on Day 1 or on Day 2 based on the randomization during the double-blind, crossover phase.

Group Type OTHER

Matching Placebo

Intervention Type OTHER

Interventions

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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.

Intervention Type OTHER

Matching Placebo

Intervention Type OTHER

Other Intervention Names

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EnteraGam™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes