Trial Outcomes & Findings for Study Evaluating the Digestibility of Serum-Derived Bovine Immunoglobulin Protein Isolate in Healthy Adults (NCT NCT02017405)

NCT ID: NCT02017405

Last Updated: 2024-09-19

Results Overview

Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

0, 180 minutes following administration of the investigational product in crossover phase.

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 1A Crossover Phase: 5.0g total daily dose of SBI on Day 1 followed by 5.0g Placebo on Day 2 Open Label Phase: 5.0g total daily dose of SBI will be taken for 14 days	5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 1B Crossover Phase: 5.0g total daily dose of Placebo on Day 1 followed by 5.0g SBI on Day 2 Open Label Phase: 5.0g total daily dose of SBI will be taken for 14 days	10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 2A Crossover Phase: 10.0g total daily dose of SBI on Day 1 followed by 10.0g Placebo on Day 2 Open Label Phase: 10.0g total daily dose of SBI will be taken for 14 days	10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 2B Crossover Phase: 10.0g total daily dose of Placebo on Day 1 followed by 10.0g SBI on Day 2. Open Label Phase: 10.0g total daily dose of SBI will be taken for 14 days	20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 3A Crossover Phase: 20.0g total daily dose of SBI on Day 1 followed by 20.0g placebo on day 2. Open Label Phase: 20.0g total daily dose of SBI will be taken for 14 days	20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 3B Crossover Phase: 20.0g total daily dose of Placebo on Day 1 followed by 20.0g SBI on Day 2 Open Label Phase: 20.0g total daily dose of SBI will be taken for 14 days
Two-day, Double-blind, Crossover Phase STARTED	9	9	7	5	5	7
Two-day, Double-blind, Crossover Phase COMPLETED	9	9	7	5	5	6
Two-day, Double-blind, Crossover Phase NOT COMPLETED	0	0	0	0	0	1
Open-label Phase STARTED	7	7	7	7	7	6
Open-label Phase COMPLETED	6	6	7	7	7	6
Open-label Phase NOT COMPLETED	1	1	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 1A Crossover Phase: 5.0g total daily dose of SBI on Day 1 followed by 5.0g Placebo on Day 2 Open Label Phase: 5.0g total daily dose of SBI will be taken for 14 days	5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 1B Crossover Phase: 5.0g total daily dose of Placebo on Day 1 followed by 5.0g SBI on Day 2 Open Label Phase: 5.0g total daily dose of SBI will be taken for 14 days	10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 2A Crossover Phase: 10.0g total daily dose of SBI on Day 1 followed by 10.0g Placebo on Day 2 Open Label Phase: 10.0g total daily dose of SBI will be taken for 14 days	10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 2B Crossover Phase: 10.0g total daily dose of Placebo on Day 1 followed by 10.0g SBI on Day 2. Open Label Phase: 10.0g total daily dose of SBI will be taken for 14 days	20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 3A Crossover Phase: 20.0g total daily dose of SBI on Day 1 followed by 20.0g placebo on day 2. Open Label Phase: 20.0g total daily dose of SBI will be taken for 14 days	20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) - 3B Crossover Phase: 20.0g total daily dose of Placebo on Day 1 followed by 20.0g SBI on Day 2 Open Label Phase: 20.0g total daily dose of SBI will be taken for 14 days
Two-day, Double-blind, Crossover Phase Withdrawal by Subject	0	0	0	0	0	1
Open-label Phase Adverse Event	1	1	0	0	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=18 Participants 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.	10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=12 Participants 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.	20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=12 Participants 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.	Total n=42 Participants Total of all reporting groups
Age, Continuous	37.3 years STANDARD_DEVIATION 9.66 • n=5 Participants	45.0 years STANDARD_DEVIATION 16.64 • n=7 Participants	39.9 years STANDARD_DEVIATION 13.26 • n=5 Participants	40.2 years STANDARD_DEVIATION 13.06 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	41 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	25 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: 0, 180 minutes following administration of the investigational product in crossover phase.

Population: During 2-day cross-over phase, subjects were randomized to receive placebo one day and active on the other. This includes all subjects who received both a placebo and an active dose.

Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.

Outcome measures

Outcome measures
Measure	5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=18 Participants Subjects who will receive either a 5.0g total daily dose of SBI on Day 1 or 5.0g SBI on Day 2 during the double-blind, crossover phase. This includes group 1A and 1B.	10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=12 Participants Subjects who will receive either a 10.0g total daily dose of SBI on Day 1 or 10.0g SBI on Day 2 during the double-blind, crossover phase. This includes group 2A and 2B.	20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=11 Participants Subjects who will receive either a 20.0g total daily dose of SBI on Day 1 or 20.0g SBI on Day 2 during the double-blind, crossover phase. This includes group 3A and 3B.	Placebo n=41 Participants Subjects who will receive a placebo dose(5,10, or 20g) on either day one or two of the crossover phase. This includes all subjects who finished the crossover phase, as all subjects received a placebo.
Concentration of Total Plasma Amino Acids Mean - 0 Minutes	2730.87 umol/mL Standard Deviation 695.33	2988.94 umol/mL Standard Deviation 758.92	2964.19 umol/mL Standard Deviation 583.50	2869.14 umol/mL Standard Deviation 647.01
Concentration of Total Plasma Amino Acids Mean - 180 Minutes	2723.72 umol/mL Standard Deviation 557.53	2785.20 umol/mL Standard Deviation 483.77	2893.69 umol/mL Standard Deviation 705.36	2736.58 umol/mL Standard Deviation 583.19

SECONDARY outcome

Timeframe: 0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing

Population: Subjects who received at least one dose of SBI. Variations in numbers from the participation flow are due to missing data of certain individuals.

Plasma samples from participants were tested for bovine IgG content using an ELISA kit with a sheep polyclonal antibody that specifically binds to bovine IgG heavy chain. The limit of quantification was determined to be 3.8 ng/ml and 4.6 ng/ml, in the two separate Elisa kits used (lot numbers 140821 and 140605).

Outcome measures

Outcome measures
Measure	5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=18 Participants Subjects who will receive either a 5.0g total daily dose of SBI on Day 1 or 5.0g SBI on Day 2 during the double-blind, crossover phase. This includes group 1A and 1B.	10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=14 Participants Subjects who will receive either a 10.0g total daily dose of SBI on Day 1 or 10.0g SBI on Day 2 during the double-blind, crossover phase. This includes group 2A and 2B.	20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) n=14 Participants Subjects who will receive either a 20.0g total daily dose of SBI on Day 1 or 20.0g SBI on Day 2 during the double-blind, crossover phase. This includes group 3A and 3B.	Placebo n=42 Participants Subjects who will receive a placebo dose(5,10, or 20g) on either day one or two of the crossover phase. This includes all subjects who finished the crossover phase, as all subjects received a placebo.
Number of Participants With Quantifiable Bovine IgG Plasma Concentration 0 minutes	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Quantifiable Bovine IgG Plasma Concentration 90 minutes	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Quantifiable Bovine IgG Plasma Concentration Post 14 days of open label dosing	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: 14 days after starting the open label phase

Population: Subjects who received at least one dose of product and had at least one stool IgG measurement. No placebo as there is no placebo group in the open label phase.

Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing.