Verification of the usefulness of food material intake for iron-related indicators in adult women

UMIN ID: UMIN000046621

Registered date:14/01/2022

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Healthy adult female
• Date of first enrollment: 2022/01/15
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Take 2 capsules daily for 6 weeks containing iron and iron deficiency improving materials
Take 2 capsules daily for 6 weeks containing iron
Take 2 capsules daily for 6 weeks that do not contain iron nor iron deficiency improving materials

Outcome(s)

• Primary Outcome: Serum iron concentration
• Secondary Outcome: Blood hemoglobin concentration Serum ferritin concentration Unsaturated iron binding capacity Total iron binding capacity Indefinite complaint questionnaire Dietary survey

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 39years-old
• Gender: Female
• Exclude criteria: Subjects who are being treated for anemia. Subjects who are judged by the study responsibility doctor to be treated for anemia by comprehensively judging from the blood index at the time of screening test. Subjects who regularly use health foods such as supplements. Subjects who have a habit of strenuous exercise that induces hemolytic anemia. Subjects who drink a lot of alcohol (60g or more / day). Subjects who have a smoking habit (Subjects less than 1 year after quitting smoking). Subjects who are losing or increasing weight excessively. Subjects who are pregnant or breast-feeding, or planning to be pregnant during the test period. Subjects who participated in tests that use other foods and pharmaceuticals, tests that apply cosmetics and pharmaceuticals, etc. within 1 month from the time of obtaining consent, and subjects who participate in other tests while participating in this study. Subjects who donated 200 mL or more of blood (including whole blood and ingredient.s) from 4 months before the screening test Subjects who may change their lifestyle such as long-term travel during the examination period. Subjects who have experienced illness or illness due to blood sampling in the past. Subjects who are judged as unsuitable for the study because of the menstrual disorders or etc. by the investigators.

Related Information

• Primary Sponsor: IMEQRD Co., Ltd.
• Source(s) of Monetary Support: Ajinomoto Co., Inc.