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Dietary Supplement

Lactoferrin-Enriched Whey for Iron-Deficiency Anemia

N/A

Recruiting

Research Sponsored by Utah State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biological sex: Female

Age ≥18 and ≤30 years;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tested on week 1 before supplementation begins, and week 16 after the final supplements have been taken.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of drinking a whey protein, rice protein, or maltodextrin drink twice a day for 16 weeks on iron levels and inflammation in active young women.

Who is the study for?

This trial is for active young women aged 18-30 with a BMI of 18-30 kg/m2 who are experiencing iron-deficiency anemia. Participants should exercise regularly, speak and understand English, and be able to give informed consent. It's not suitable for those outside these criteria.

What is being tested?

The study tests the effects of drinks enriched with lactoferrin (200 mg), iron (6 mg), and vitamin B12 (5.2 µg) on iron metabolism and inflammation in females when consumed twice daily over 16 weeks. The drinks are based on whey protein, rice protein, or maltodextrin.

What are the potential side effects?

Potential side effects may include gastrointestinal discomfort due to lactoferrin or iron intake such as constipation or diarrhea, allergic reactions to any component in the drink mixtures like whey or rice protein.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am female.

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I am between 18 and 30 years old.

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I can speak and understand English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tested on week 1 before supplementation begins, and week 16 after the final supplements have been taken.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tested on week 1 before supplementation begins, and week 16 after the final supplements have been taken.

This trial's timeline: 3 weeks for screening, Varies for treatment, and tested on week 1 before supplementation begins, and week 16 after the final supplements have been taken. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Serum Ferritin

Secondary study objectives

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

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

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

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Lactoferrin in Whey ProteinActive Control1 Intervention

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.

Group II: Lactoferrin in Rice ProteinActive Control1 Intervention

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.

Group III: Lactoferrin ControlActive Control1 Intervention

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.

0 / 3Eligibility criteria met