UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051585 |
|---|---|
| Receipt number | R000058855 |
| Scientific Title | Effect of agricultural products intake on body composition |
| Date of disclosure of the study information | 2025/07/12 |
| Last modified on | 2025/02/22 20:13:05 |
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Basic information
Public title
Effect of agricultural products intake on body composition
Acronym
Effect of agricultural products intake on body composition
Scientific Title
Effect of agricultural products intake on body composition
Scientific Title:Acronym
Effect of agricultural products intake on body composition
Region
| Japan |
Condition
Condition
Healthy Female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of body composition by foods intake in women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat Body percentage
Muscle mass
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention group: Daily intake of agricultural products for 8 weeks
Interventions/Control_2
Control group: Not daily intake of agricultural products for 8 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Female
Key inclusion criteria
A female who has obtained the consent of the person
Key exclusion criteria
1) Subjects who have a serious disease.
2) Subjects who have participated in other clinical study within the past 2 month prior.
3) Subjects who take the test-food at least once a week.
4) Subjects with previous medical history of the allergy to food or have had them in the past.
5) Subjects who are judged as unsuitable for the study by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Mita |
Organization
Sugiyama jogakuen university
Division name
Department of Human Nutrition, School of Life Studies
Zip code
464-8662
Address
17-3 Hoshigaoka-motomachi, Chikusa-ku, Nagoya, Aichi
TEL
0527811186
yukiko@sugiyama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Mita |
Organization
Sugiyama jogakuen University
Division name
Department of Human Nutrition, School of Life Studies
Zip code
464-8662
Address
17-3 Hoshigaoka-motomachi, Chikusa-ku, Nagoya, Aichi
TEL
0527811186
Homepage URL
yukiko@sugiyama-u.ac.jp
Sponsor or person
Institute
Sugiyama jogakuen University
Institute
Department
Personal name
Yukiko Mita
Funding Source
Organization
Nissui Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sugiyama jogakuen university
Address
17-3 Hoshigaoka-motomachi, Chikusa-ku, Nagoya, Aichi
Tel
0527811186
yukiko@sugiyama-u.ac.jp
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
| 2025 | Year | 07 | Month | 12 | 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
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058855
