UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062970 |
|---|---|
| Receipt number | R000072097 |
| Scientific Title | Assessment of nutrient intake and validation of biomarkers in Japanese adults: a cross-sectional study |
| Date of disclosure of the study information | 2026/09/18 |
| Last modified on | 2026/09/18 09:36:14 |
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Basic information
Public title
Cross-sectional study to assess dietary intake and nutritional status, with a focus on food A consumption, among Japanese adults
Acronym
J-FDAN (Japanese food A-focused Dietary and Nutritional Assessment) Study
Scientific Title
Assessment of nutrient intake and validation of biomarkers in Japanese adults: a cross-sectional study
Scientific Title:Acronym
J-NIBV (Japanese Nutrient Intake and Biomarker Validation Study) Study
Region
| Japan |
Condition
Condition
Nutritional status in Japanese adults, including vitamin status and food A intake
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association of vitamin intake and dietary sources assessed by detailed dietary surveys with serum vitamin or vitamin metabolites concentrations among Japanese adults living in Hokkaido.
Basic objectives2
Others
Basic objectives -Others
The study will evaluate the validity of serum and urinary new biomarkers and bioelectrical impedance-derived indices as markers of food A intake.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between vitamin or vitamin metabolites in serum and vitamin intake estimated from food A (dietary record)
Key secondary outcomes
1. Food- and food-group-specific contributions to vitamin intake and the proportion derived from food A, estimated from the 4-day weighed d
2. Portion size and frequency of food A intake
3. Serum and urinary vitamin or vitamin metabolite concentrations
4. Associations of serum fatty acidand new biomarkers
5. Body composition and phase angle assessed by bioelectrical impedance analysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy Japanese community-dwelling adults aged 30 years or older and younger than 70 years
2. Able to complete weighed dietary records with photographs during the specified period and attend the study site for blood and urine collect
3. Able to provide written informed consent
Key exclusion criteria
1. Pregnant or lactating women
2. Use of supplements or nutrient-fortified foods containing specialty vitamin and fatty acid of food A at least five times per week
3. Chronic renal failure, autoimmune disease, inflammatory bowel disease, cancer, liver disease, diabetes, or an eating disorder; or current meosteoporosis
4. Medical prohibition of sun exposure, such as xeroderma pigmentosum
5. Extreme dietary restriction
6. Planned major change in eating behavior during the study period (late August through late November), such as starting a weight-loss progra
7. Dietitians or registered dietitians
8. Outdoor activity during 10:00-15:00 for at least 2 hours per day on at least 5 days per week
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Uchida |
Organization
Nissui Corporation
Division name
Food and Health Science Research Institute
Zip code
105-8676
Address
1-3-1 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
080-8077-6127
kenji_uchida@nissui.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Uchida |
Organization
Nissui Corporation
Division name
Food and Health Science Research Institute
Zip code
105-8676
Address
1-3-1 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
080-8077-6127
Homepage URL
kenji_uchida@nissui.co.jp
Sponsor or person
Institute
Nissui Corporation
Institute
Department
Personal name
Kenji Uchida
Funding Source
Organization
Nissui Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Metropolitan University; Tohoku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamazaki ENT Ethics Committee
Address
1-16, Kita 11-jo Nishi 14-chome, Kita-ku, Sapporo
Tel
080-1869-2585
shinsuke-n@kyowa-t.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional observational study with prospective data collection among healthy Japanese community-dwelling adults aged 30 to Participants will be recruited and assessed at Kyowa Trial Co., Ltd. Up to 250 participants will be enrolled, with a target final analysis populatioand attrition. The target analysis population consists of 25 participants in each of eight sex-by-age strata (30-39, 40-49, 50-59, and 60-69 years),study visit, participants will complete food weighing records and questionnaires. At a single study visit, blood, first-morning urine, and hair samanthropometry and bioelectrical impedance measurements will be performed. The study will examine the association of vitamin intake and dvitamin metabolites concentration and will assess serum fatty acid of food A, serum and urinary new biomarkers, and bioelectrical impedancefood A intake. The study will be registered in UMIN-CTR after IRB approval and before participant recruitment or enrollment begins.
Management information
Registered date
| 2026 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072097
