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| Name | Class |
|---|---|
| TurtleTree Labs Inc | UNKNOWN |
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Overall Objective: To determine the efficacy of rbLf supplementation in a healthy adult population, specifically with regard to iron regulation (primary), gut health (secondary), and immune function (secondary). Purpose: The purpose of this study is to determine the effects of rbLf on iron regulation, exercise performance, gut health, and immune function as compared to cow's milk derived bLf.
Participants: To account for an approximate ~10% dropout rate (and rounding up to ensure equal number of enrolled participants per group), n=25 per group for males (N=50) and n=30 per group for females (N=60) will be enrolled for a total sample size of N=110.
Procedures: Participation in this study will include 6 in-person visits over 14 weeks. Anemia will be checked and excluded at the first visit using a single finger prick, followed by a 10-20 min exercise test on a treadmill to evaluate exercise capacity. On visit 2 participants will perform three 3-15 minute exercise tests on a treadmill with rest in between each test in order to determine exercise performance. A finger prick will be performed before and after each run to determine lactate levels. After visits 2 participants will be randomized to their respective supplement group recombinant Bovine Lactoferrin supplement (rbLf) (Male and Fame), a bovine-milk derived Lactoferrin supplement (Female), or a placebo (Male) once daily for 4 weeks. Blood samples will be obtained prior to and after each supplement phase to determine change in iron levels and red blood cell capacity. After a 2-week washout participants will return to complete the same testing outcomes and will receive the subsequent supplement. At visit 6 a final blood sample will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin | Experimental | After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start bovine milk derived lactoferrin for 4 weeks. |
|
| Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin | Active Comparator | After a 2-week run-in period, this arm will begin treatment with bovine milk derived lactoferrin and then following a 2-week washout start recombinant bovine lactoferrin for 4 weeks. |
|
| Males: Recombinant Bovine Lactoferrin (rbLf), then placebo | Active Comparator | After a 2-week run-in period, this arm will begin treatment with recombinant bovine lactoferrin for 4 weeks and following a 2-week washout start placebo for 4 weeks. |
|
| Males: Placebo, then recombinant bovine lactoferrin (rbLf) | Placebo Comparator | After a 2-week run-in period, this arm will begin treatment with placebo for 4 weeks and following a 2-week washout start recombinant bovine lactoferrin for 4 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Bovine Lactoferrin | Dietary Supplement | Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in serum iron (mcg/dL) | change in serum blood values obtained before and after supplementation | baseline to 4 weeks |
| Change in ferritin iron (ng/mL) | change in blood values obtained before and after supplementation | baseline to 4 weeks |
| Change in red blood cell count (trillion cells/L) | change in blood values obtained before and after supplementation | baseline to 4 weeks |
| change in iron binding capacity (mcg/dL) | change in blood values obtained before and after supplementation | baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change in time to exhaustion running (seconds) | change in treadmill running to exhaustion before and after supplementation | baseline to 4 weeks |
| change on tumor necrosis factor-a (pg/mL) | change in blood values obtained before and after supplementation |
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Inclusion Criteria:
18-42 years
Body mass index less than 35 kg/m^2
Finger prick hemoglobin levels fitting within "normal range"
Active: meeting American College of Sports Medicine exercise guidelines or exercising more than 2 days per week of
● For females specifically:
Pre-menopausal: experiencing a regular period with no signs of perimenopause or menopause.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abbie Smith-Ryan, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Physiology Laboratory | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina. Additionally, clear aims and scope of the data request must be included.
9-24 Months after publication
Clear specific study aims and ethics approval must be present.
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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Randomized cross-over design
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Double-Blind
| Bovine Milk-Derived Lactoferrin | Dietary Supplement | Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled. |
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| Placebo | Dietary Supplement | Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled. |
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| baseline to 4 weeks |
| change in interleukin-6 (pg/ml) | change in blood values obtained before and after supplementation | baseline to 4 weeks |