Healthy
Conditions
Keywords
Digestibility, Healthy volunteers, serum-derived bovine immunoglobulin protein isolate, bovine IgG, adults
Brief 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.
Detailed description
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.
Interventions
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.
OTHERMatching Placebo
Sponsors
Entera Health, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Total Plasma Amino Acids | 0, 180 minutes following administration of the investigational product in crossover phase. | Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 0 and 90 minutes following investigational product dosing during crossover phase; and after 14 days of open label dosing | 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). |
| Bovine IgG Concentration in Stool | 14 days after starting the open label phase | Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 18 |
| 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. | 12 |
| 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. | 12 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Open-label Phase | Adverse Event | 1 | 1 | 0 | 0 | 0 | 0 |
| Two-day, Double-blind, Crossover Phase | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Total |
|---|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 9.66 | 45.0 years STANDARD_DEVIATION 16.64 | 39.9 years STANDARD_DEVIATION 13.26 | 40.2 years STANDARD_DEVIATION 13.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 12 Participants | 12 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 3 Participants | 2 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 9 Participants | 9 Participants | 25 Participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 8 Participants | 6 Participants | 5 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 12 | 0 / 11 | 0 / 42 | 0 / 14 | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 4 / 18 | 0 / 12 | 3 / 11 | 0 / 42 | 7 / 14 | 4 / 14 | 5 / 13 |
| serious Total, serious adverse events | 0 / 18 | 0 / 12 | 0 / 14 | 0 / 42 | 0 / 14 | 0 / 14 | 0 / 13 |
Outcome results
Primary
Concentration of Total Plasma Amino Acids
Plasma amino acid concentrations (umol/mL) were measured after administration of SBI or Placebo during the Cross-over phase.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Concentration of Total Plasma Amino Acids | Mean - 0 Minutes | 2730.87 umol/mL | Standard Deviation 695.33 |
| 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Concentration of Total Plasma Amino Acids | Mean - 180 Minutes | 2723.72 umol/mL | Standard Deviation 557.53 |
| 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Concentration of Total Plasma Amino Acids | Mean - 0 Minutes | 2988.94 umol/mL | Standard Deviation 758.92 |
| 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Concentration of Total Plasma Amino Acids | Mean - 180 Minutes | 2785.20 umol/mL | Standard Deviation 483.77 |
| 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Concentration of Total Plasma Amino Acids | Mean - 0 Minutes | 2964.19 umol/mL | Standard Deviation 583.5 |
| 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Concentration of Total Plasma Amino Acids | Mean - 180 Minutes | 2893.69 umol/mL | Standard Deviation 705.36 |
| Placebo | Concentration of Total Plasma Amino Acids | Mean - 180 Minutes | 2736.58 umol/mL | Standard Deviation 583.19 |
| Placebo | Concentration of Total Plasma Amino Acids | Mean - 0 Minutes | 2869.14 umol/mL | Standard Deviation 647.01 |
Secondary
Bovine IgG Concentration in Stool
Change from baseline in Stool bovine IgG concentration following 14 days of open label dosing.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Bovine IgG Concentration in Stool | 100.79 pg/mg | Standard Deviation 80.01 |
| 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Bovine IgG Concentration in Stool | 160.20 pg/mg | Standard Deviation 121.09 |
| 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Bovine IgG Concentration in Stool | 111.59 pg/mg | Standard Deviation 76.5 |
Secondary
Number of Participants With Quantifiable Bovine IgG Plasma Concentration
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).
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 0 minutes | 0 Participants |
| 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 90 minutes | 0 Participants |
| 5g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | Post 14 days of open label dosing | 0 Participants |
| 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 90 minutes | 0 Participants |
| 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 0 minutes | 0 Participants |
| 10g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | Post 14 days of open label dosing | 0 Participants |
| 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 90 minutes | 0 Participants |
| 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 0 minutes | 0 Participants |
| 20g Serum-derived Bovine Immunoglobulin Protein Isolate (SBI) | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | Post 14 days of open label dosing | 0 Participants |
| Placebo | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 90 minutes | 1 Participants |
| Placebo | Number of Participants With Quantifiable Bovine IgG Plasma Concentration | 0 minutes | 1 Participants |