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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051959
Enrollment
80
Registered
2023-08-21
Start date
2023-08-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None (Healthy subjects)

Interventions

Ingestion of dairy ingredient for 4 weeks. Ingestion of placebo for 4 weeks.

Sponsors

Kyushu University of Health and Welfare
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)Female 2)Subjects between 18 to 50 years old. 3)Serum ferritin >= 12 ng/mL

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
indices of iron metabolism

Secondary

MeasureTime frame
indices of iron metabolism

Countries

Japan

Contacts

Public ContactHiroki Yoshida

Kyushu University of Health and Welfare Department of Pharmacy, Faculty of Pharmaceutical Sciences

h-yoshida@phoenix.ac.jp0982-23-5574

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026