Search / Trial NCT06232642

Effects of Lactoferrin-enriched Whey on Iron Status in Females

Launched by UTAH STATE UNIVERSITY · Jan 29, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Lactoferrin Iron Serum Ferritin Iron Status

ClinConnect Summary

This clinical trial is exploring how a special drink made with whey protein, enriched with lactoferrin, iron, and vitamin B12, affects iron levels in young women who are physically active. The researchers want to see if drinking this supplement twice a day for 16 weeks can improve iron status, reduce inflammation, and enhance important blood markers related to iron, compared to drinks made with rice protein or maltodextrin.

To join the study, participants need to be females aged 18 to 30 who exercise regularly (at least 3 times a week). They should have a healthy weight and be able to understand and communicate in English. However, some people may not be eligible, such as those with certain medical conditions, allergies to the ingredients, or those who consume a lot of iron-rich foods or alcohol. Participants will have their blood tested at the start and end of the study to measure changes in their iron levels and overall health.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • • 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
  • Exclusion Criteria:
  • • 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

About Utah State University

Utah State University (USU) is a distinguished public research institution committed to advancing knowledge and improving health outcomes through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, USU leverages its expertise in various fields, including health sciences, engineering, and behavioral research, to conduct rigorous clinical trials. The university fosters a supportive environment for researchers and participants alike, ensuring adherence to ethical standards and regulatory requirements. USU's mission is to contribute to the betterment of community health through evidence-based findings and to translate research discoveries into practical applications that enhance the quality of life.

Locations

Logan, Utah, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0