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Dietary Supplement

Lactoferrin in Whey Protein for Iron-Deficiency Anemia

N/A

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Serum Ferritin

Secondary outcome measures

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

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

Find a Location

Who is running the clinical trial?

Utah State UniversityLead Sponsor

44 Previous Clinical Trials

4,322 Total Patients Enrolled

BUILD DairyUNKNOWN

1 Previous Clinical Trials

15 Total Patients Enrolled

Glanbia NutritionalsIndustry Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals who are below the age of 30 participate in this research trial?

"To partake in this clinical investigation, candidates must be over 18 years of age but under the age limit of 30."

Answered by AI

Am I eligible to enroll in this research trial?

"To meet the qualifications for this study, potential participants must have a diagnosis of iron-deficiency anemia and fall within the age range of 18 to 30. The trial is currently accepting approximately 90 individuals as candidates."

Answered by AI

Is this clinical trial currently open for enrollment?

"As per the information on clinicaltrials.gov, this particular trial is no longer seeking participants. The trial was initially posted on March 1st, 2024 and underwent its last update on January 29th, 2024. Nevertheless, there are currently other ongoing studies actively recruiting individuals at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lactoferrin-Iron Study

2024. "Lactoferrin-Iron Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06232642.