Effects of Lactoferrin-enriched Whey on Iron Status in Females
Status unconfirmed · Not applicable
Conditions studied: Serum Ferritin
In brief
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).
Key facts
- Study ID
- NCT06232642
- Run by
- Utah State University
- People needed
- 82
- Starts
- 2024-03-01
- Expected to finish
- 2025-05-30
- Last updated by the study team
- 2025-01-28
Who can join
Age: 18 and older, up to 30. Sex: female. Healthy volunteers: accepted.
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
Where it is running
- Center for Human Nutrition Studies — Logan, Utah, United States
Full record on ClinicalTrials.gov
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