Effects of Lactoferrin-enriched Whey on Iron Status in Females

NCT06232642 | Active Not Recruiting

• 1 other identifier: 13314
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this work is to study the effects of twice daily ingestion of a whey protein, rice protein, or maltodextrin drink enriched with lactoferrin- (200 mg), iron (6 mg) and vitamin B12 (5.2 µg) for 16-weeks on iron metabolism and inflammatory markers in active young females. It is expected that the females consuming containing lactoferrin-, iron, and vitamin B12-enriched whey will 1) improve serum ferritin status; 2) reduce inflammation; 3) improve markers of iron metabolism, such as Hemoglobin (Hb), red blood cell count (RBC) and hematocrit (Hc) compared to women who consume the rice protein or maltodextrin control drink. Blood will be drawn before the beginning of the supplemental period (week 0) and end the end of the intervention phase (week 16).

Conditions

Serum Ferritin

Keywords

Lactoferrin; Iron; Serum Ferritin; Iron Status

Outcome Measures

Primary Outcomes (1)

• Serum Ferritin

  Free Serum Ferritin measured via enzymatic detection at LabCorp Inc. as proxy of iron absorption.

  Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.

Secondary Outcomes (6)

• Inflammatory cytokine biomarker (IL-6) concentrations in plasma samples

  Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.

• Inflammatory cytokine biomarker (C-reactive protein) concentrations in plasma samples

  Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.

• Inflammatory cytokine biomarker (TNF-alpha) concentrations in plasma samples

  Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.

• Marker of Iron metabolism Red Blood Cell Count

  Tested at week 0 before supplementation begins, and on week 16 after the final supplements have been taken.

• Marker of Iron metabolism Hematocrit

  Tested at week 0 before supplementation begins, and week 16 after the final supplements have been taken.

Study Arms (3)

Lactoferrin in Whey Protein

ACTIVE COMPARATOR

Lactoferrin (200 mg), iron (6 mg), and B12 (5.2 ug) in a whey protein isolate drink (20 grams of protein) to be taken 2 times daily; once before the morning meal and once before the evening meal.

Dietary Supplement: Lactoferrin, iron and B12 in Whey Protein

Lactoferrin in Rice Protein

ACTIVE COMPARATOR

Lactoferrin (200 mg), iron (6 mg), and B12 (5.2 ug) in a rice protein drink (20 grams of protein) to be taken 2 times daily; once before the morning meal and once before the evening meal.

Dietary Supplement: Lactoferrin, Iron and B12 in Rice Protein

Lactoferrin Control

ACTIVE COMPARATOR

Lactoferrin (200 mg), iron (6 mg), and B12 (5.2 ug) in a maltodextrin drink (0 grams of protein) to be taken 2 times daily; once before the morning meal and once before the evening meal.

Dietary Supplement: Lactoferrin, Iron and B12 in Maltrodextrin

Interventions

Lactoferrin, iron and B12 in Whey Protein DIETARY_SUPPLEMENT

Chocolate Flavored Whey Protein Isolate Powder with (200mg Lactoferrin, 6 mg Iron, 5.2 ug B12)

Lactoferrin in Whey Protein

Lactoferrin, Iron and B12 in Rice Protein DIETARY_SUPPLEMENT

Chocolate Flavored Rice Protein Isolate with (200mg Lactoferrin, 6mg Iron, 5.2 ug B12)

Lactoferrin in Rice Protein

Lactoferrin, Iron and B12 in Maltrodextrin DIETARY_SUPPLEMENT

Chocolate Flavored (200mg Lactoferrin, 6 mg Iron, 5.2 ug B12)

Lactoferrin Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Biological sex: Female
• Age ≥18 and ≤30 years;
• BMI ≥18 and ≤30 kg/m2;
• For the safety of the participant and proper consent of the procedures, subjects
• must be able to speak and understand English to participate in this study,
• which will be determined at the discretion of study staff;
• Actively engaged in exercise/training ≥3 and ≤12 times per week with each session being from ≥30min to ≤3 hours in length of moderate to vigorous activity. activities that meet this criterion may include but are not limited to: hiking, weightlifting, volleyball, basketball, soccer, or others sport or activities' that involves strenuous physical activity

You may not qualify if:

• Use of medications or supplements that are known to affect the study outcome measures (e.g., NSAIDs, corticosteroids, iron containing supplements) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for this study.
• Allergy to rice and/or whey protein.
• Pregnant or lactating.
• \>7 meals/week containing red meat and/or shellfish (iron-rich foods).
• Hb1Ac \>6.4%
• Consuming \>14 alcoholic drinks per week;
• Use of cigarettes (or other tobacco products) in last 3 months;
• Diagnoses of active malignancy, congestive heart failure, diabetes mellitus or chronic obstructive pulmonary disease;
• Any inflammatory diseases (e.g., autoimmune diseases, coeliac disease, glomerulonephritis, hepatitis, inflammatory bowel disease, arthritis).
• Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers not an appropriate candidate for this study, including non-compliance with screening appointments or study visits

Sponsors & Collaborators

• Utah State University: lead
• Glanbia Nutritionals: collaborator

Study Sites (1)

Center for Human Nutrition Studies

Logan, Utah, 84322, United States

Location

Related Publications (24)

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MeSH Terms

Interventions

Lactoferrin; Iron; Vitamin B 12; Whey Proteins

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Supplement arms will be marked with a random number code assigned by a non-participating researcher immediately after supplements are prepared. Supplements will be provided to participants in unmarked sachets.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study has three arms to which participants will be randomly assigned to: Arm 1: A lactoferrin- (200 mg), iron (6 mg) and Vitamin B12 (5.2µg)- enriched whey drink (10 g protein; FerriUpTM). Arm 2: A protein control (rice protein containing drink matched for protein, iron and B12). Arm 3: A lactoferrin control (maltodextrin containing drink matched for lactoferrin, iron, and B12). The parallel design 16 weeks in length with blood draws before and after intervention period to assess iron status, and markers of iron metabolism and inflammation.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 31, 2024
• Study Start: March 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: January 28, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: From January 2025, and indefinitely afterward.
• Access Criteria: Freely Available

Locations

US (1)