Effects of a dairy ingredient on iron metabolism in healthy female subjects: a randomized, double-blind, placebo-controlled, parallel group, comparative superiority trial

Not Applicable

• Conditions: one (Healthy subjects)

• Registration Number: JPRN-UMIN000051959
• Lead Sponsor: Kyushu University of Health and Welfare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-21
• Study Completion: 2023-12-15
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

1)Blood hemoglobin < 12 g/dL 2)Subjects who undergoes treatment for iron deficiency or anemia 3)Menopausal 4)Subjects who plans to donate blood during the test period 5)Subjects who regularly consume foods containing a dairy ingredient to be evaluated. 6)Subjects who take medicines or functional foods during the pre-test period, which might affect their iron metabolism. 7)Subjects who cannot stop taking medicines or functional foods during the test period, which might affect their iron metabolism. 8)Subjects who have serious disease in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system etc. Or those who have serious medical history of these. 9)Subjects having a milk allergy. 10)Subjects who have medical history of drug allergy or severe food allergy 11)Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study. 12)Subjects who donated 400 mL of their blood within 12 weeks before the beginning of test-food intakes, or not less than 200 mL of their blood during the pre-test period. 13)Others who have been determined as ineligible for the research subject of this study, judging from the principal researcher/doctor's opinions on the findings of their background, physical observations, medical checkup, physical/clinical examination, and so on.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
indices of iron metabolism

Secondary Outcome Measures

Name	Time	Method
indices of iron metabolism