UMIN ID: UMIN000056227
Registered date:21/11/2024
Exploratory research on dietary content and blood and urine biomarkers for the development of techniques to optimize dietary balance
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Healthy adults |
| Date of first enrollment | 2025/01/25 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Participants restrict their intake of vegetables, fruits, etc. for two days, and then consume 350 g of vegetables and 200 g of fruits per day for two days. |
Outcome(s)
| Primary Outcome | Assessment of the relationship between dietary components such as vegetables, fruits, meat, and salt and their biomarker components in blood and urine |
|---|---|
| Secondary Outcome | Items of general biochemical values in blood and urine, intestinal flora, height and weight, body composition, blood pressure, index of vegetable intake status from fingertips by optical skin carotenoid content measuring device, questionnaire on daily vegetable and fruit intake |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 65years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) Pregnant or possibly pregnant and lactating women. (2) People who have a disease for which they are receiving continuous treatment, medication, or lifestyle guidance and who are deemed unsuitable as subjects by the research physician at the institution providing informed consent. (3) Those receiving continuous medication and dietary guidance from a physician or dietitian. (4) Current participation in another clinical trial. (5) Subjects who donated whole blood for less than one month. (6) Food allergies to vegetables, fruits, or other intervention foods. (7) Other subjects are deemed inappropriate by the principal investigator of the institution where informed consent is to be provided. |
Related Information
| Primary Sponsor | National Institute of Biomedical Innovation, Health and Nutrition |
|---|---|
| Secondary Sponsor | Healthcare Systems Co., Ltd. National Agriculture and Food Research Organization |
| Source(s) of Monetary Support | others |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hirohito Ishikawa |
| Address | 1-14-18 Shirokane, Showa-ku, Nagoya City, Aichi Prefecture Japan 466-0058 |
| Telephone | 052-734-8885 |
| oyama.suzuka@hc-sys.jp | |
| Affiliation | Healthcare Systems Co., Ltd. Clinical Research Department |
| scientific contact | |
| Name | Yuko TOUSEN |
| Address | Kento Innovation Park, NK Building, 3-17 Senrioka Shinmachi, Settsu-shi, Osaka 566-0002, Japan Japan |
| Telephone | 06-6384-1120 |
| tousen@nibiohn.go.jp | |
| Affiliation | National Institutes of Biomedical Innovation, Health and Nutrition Department of Food Function and Labeling |