## Protocol Section
### Identification Module
**NCT ID:** NCT06428357

**Brief Title:** Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

**Official Title:** Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation

#### Organization Study ID Info
**ID:** 23-3039
#### Organization
**Class:** OTHER
**Full Name:** University of North Carolina, Chapel Hill
### Status Module
#### Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** TurtleTree Labs Inc

#### Lead Sponsor

**Class:** OTHER

**Name:** University of North Carolina, Chapel Hill

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Exercise Performance

**Keywords:**

- Iron regulation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Randomized cross-over design

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Double-Blind

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 110

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: Recombinant Bovine Lactoferrin

- Dietary Supplement: Bovine Milk-Derived Lactoferrin

**Label:** Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: Recombinant Bovine Lactoferrin

- Dietary Supplement: Bovine Milk-Derived Lactoferrin

**Label:** Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: Recombinant Bovine Lactoferrin

- Dietary Supplement: Placebo

**Label:** Males: Recombinant Bovine Lactoferrin (rbLf), then placebo

**Type:** ACTIVE_COMPARATOR

#### Arm Group 4

**Description:** 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.

**Intervention Names:**

- Dietary Supplement: Recombinant Bovine Lactoferrin

- Dietary Supplement: Placebo

**Label:** Males: Placebo, then recombinant bovine lactoferrin (rbLf)

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin

- Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin

- Males: Placebo, then recombinant bovine lactoferrin (rbLf)

- Males: Recombinant Bovine Lactoferrin (rbLf), then placebo

**Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.

**Name:** Recombinant Bovine Lactoferrin

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Females: Bovine milk derived lactoferrin (cmdLf), then Recombinant bovine lactoferrin

- Females: Recombinant Bovine Lactoferrin (rbLf), then Bovine milk derived Lactoferrin

**Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.

**Name:** Bovine Milk-Derived Lactoferrin

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- Males: Placebo, then recombinant bovine lactoferrin (rbLf)

- Males: Recombinant Bovine Lactoferrin (rbLf), then placebo

**Description:** Participants will take a single dose equal to 3 capsules daily before a meal for 4 weeks. Meal timing is not controlled.

**Name:** Placebo

**Other Names:**

- Sugar Pill

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

**Description:** change in serum blood values obtained before and after supplementation

**Measure:** Change in serum iron (mcg/dL)

**Time Frame:** baseline to 4 weeks

**Description:** change in blood values obtained before and after supplementation

**Measure:** Change in ferritin iron (ng/mL)

**Time Frame:** baseline to 4 weeks

**Description:** change in blood values obtained before and after supplementation

**Measure:** Change in red blood cell count (trillion cells/L)

**Time Frame:** baseline to 4 weeks

**Description:** change in blood values obtained before and after supplementation

**Measure:** change in iron binding capacity (mcg/dL)

**Time Frame:** baseline to 4 weeks

#### Secondary Outcomes

**Description:** change in treadmill running to exhaustion before and after supplementation

**Measure:** change in time to exhaustion running (seconds)

**Time Frame:** baseline to 4 weeks

**Description:** change in blood values obtained before and after supplementation

**Measure:** change on tumor necrosis factor-a (pg/mL)

**Time Frame:** baseline to 4 weeks

**Description:** change in blood values obtained before and after supplementation

**Measure:** change in interleukin-6 (pg/ml)

**Time Frame:** baseline to 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 18-42 years
* Body mass index less than 35 kg/m\^2
* Finger prick hemoglobin levels fitting within "normal range"

  * Males: 14-18g/dL
  * Females: 12-16g/dL
* 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:

* Clinically diagnosed iron-deficiency anemia, pagophagia, hemochromatosis, or other blood or iron related medical conditions.
* Allergy or intolerance to milk, egg, soy, peanut, wheat, coconut, or almond dairy
* Smokers or vapers of nicotine or nicotine products
* Immunocompromised or diagnosed with Type I or II diabetes
* Irritable Bowel Disease, Crohn's disease, Celiacs
* Bowel movements less than three times per week, or clinically constipated
* Oral contraceptive users that have combined iron supplementation, or non-monophasic oral contraceptive users.
* Pregnant or nursing
* Chronic eczema or clinically diagnosed asthma.
* Current antibiotic use or antibiotic use within the past 6 weeks
* If flu, corona virus, or cold occurs, subject will remain in the study with their original scheduled visits, but immune values will be excluded.
* Vegan (due to supplement ingredients).

**Healthy Volunteers:** True

**Maximum Age:** 42 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** abbsmith@email.unc.edu

**Name:** Abbie E. Smith-Ryan, PhD

**Phone:** 9199622574

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chapel Hill

**Contacts:**

***Contact 1:***

- **Name:** Abbie Smith-Ryan

- **Role:** CONTACT

**Country:** United States

**Facility:** Applied Physiology Laboratory

**State:** North Carolina

**Zip:** 27599

#### Overall Officials

**Official 1:**

**Affiliation:** University of North Carolina, Chapel Hill

**Name:** Abbie Smith-Ryan, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Access Criteria:** Clear specific study aims and ethics approval must be present.

**Description:** 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.

**Info Types:**

- STUDY_PROTOCOL

**IPD Sharing:** YES

**Time Frame:** 9-24 Months after publication

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Micro

- Name: Micronutrients

### Intervention Browse Module - Browse Leaves

- ID: M10799

- Name: Lactoferrin

- Relevance: HIGH

- As Found: Peripheral Neuropathy

- ID: M10533

- Name: Iron

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007781

- Term: Lactoferrin

### Misc Info Module

- Version Holder: 2024-05-31
