- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02017405
Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults
A Randomized, Crossover Clinical Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate (SBI) in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Cary, North Carolina, United States, 27518
- PMG Research of Cary
-
Raleigh, North Carolina, United States, 27612
- Wake Research Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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. |
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 Names:
|
Other: 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. |
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 Names:
|
Other: 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. |
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 Names:
|
Other: Matching Placebo
Placebo will be taken either on Day 1 or on Day 2 based on the randomization during the double-blind, crossover phase.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amino Acid Metabolism
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bovine IgG Plasma Concentration
Time Frame: 1 day
|
1 day
|
Bovine IgG Plasma Concentration
Time Frame: 2 weeks
|
2 weeks
|
Bovine IgG Concentration in Stool
Time Frame: 2 weeks
|
2 weeks
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of Adverse Events
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EH4001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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