Search / Trial NCT06232642

Effects of Lactoferrin-enriched Whey on Iron Status in Females

Launched by UTAH STATE UNIVERSITY · Jan 29, 2024

Trial Information

Current as of October 03, 2024

Recruiting

Keywords

Lactoferrin Iron Serum Ferritin Iron Status

Description

BACKGROUND AND SIGNIFICANCE Iron deficiency is a major cause of disease burden worldwide, affecting 1-2 billion people globally. While often considered an issue in developing nations, low iron intake is a growing problem in the US and other industrialized nations, particularly affecting women of reproductive age. In the US, 20% of women aged 18-45 have insufficient iron intake (below the EAR of 18 mg/day) and this number that has been growing over the last decades. This is, in part, due to reduced concentrations in foods and lower intakes of iron-containing foods. Moreover, iron-rich food ...

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 Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Logan, Utah, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0