UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055952 |
|---|---|
| Receipt number | R000063910 |
| Scientific Title | Research on psychosomatic function with nutritional supplements. -placebo-controlled crossover trial- |
| Date of disclosure of the study information | 2024/10/25 |
| Last modified on | 2026/01/23 14:27:04 |
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Basic information
Public title
Identification of changes in nutritional status and psychosomatic function during supplement use.
Acronym
Identification of changes in nutritional status and psychosomatic function during supplement use.
Scientific Title
Research on psychosomatic function with nutritional supplements. -placebo-controlled crossover trial-
Scientific Title:Acronym
Research on psychosomatic function with nutritional supplements.
Region
| Japan |
Condition
Condition
Healthy Subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding of changes in human cognitive and psychosomatic function through micronutrient supplementation with food supplements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Comparison of serum brain-derived neurotrophic factor concentrations
-Comparison of changes in anxiety scale and competitive psychology
Key secondary outcomes
-Comparison of attention and concentration measurements
-Comparison of changes in blood vitamins, various intermediary metabolites, antioxidant effects, etc.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo food intake (14 days) --> Washout period (4 weeks or more) --> Test food intake (14 days)
Interventions/Control_2
Test food intake (14 days) --> Washout period (4 weeks or more) --> Placebo food intake (14 days)
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. healthy men and women aged between 18 and 39 years at the time of consent
2. Persons who have been fully informed of the purpose and content of the research, have the capacity to consent, understand it well, volunteer to participate in the study, and give their written consent to participate in the study.
Key exclusion criteria
1. those taking daily dietary supplements or medicines and who are unable to discontinue them during the study.
2. smokers or those who have not quit smoking for at least 3 months
3. have a current or previous history of allergy to any of the ingredients of the food being studied
4. who are pregnant or breastfeeding, or who may become pregnant or plan to become pregnant or breastfeed during the study period.
5. persons suffering from gastrointestinal disorders resulting in malabsorption, such as dyspepsia syndrome or gastrectomy
6. who are currently participating in another clinical trial or who have participated in another clinical trial or clinical study within the last month prior to the date of consent,
7. who are currently participating in another clinical trial, or who have participated in another clinical trial or study within the last month prior to the date of consent, or who intend to participate during this trial; or
currently receiving regular hospital treatment for any medical condition
8. any other person who, in the opinion of the investigator or physician, is unsuitable as a subject for this trial.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Naho |
| Middle name | |
| Last name | Serizawa |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11, Akabanedai, Kita-ku, Tokyo
TEL
03-5924-2819
serizawa@toyo.jp
Public contact
Name of contact person
| 1st name | Naho |
| Middle name | |
| Last name | Serizawa |
Organization
Toyo University
Division name
Faculty of Health and Sports Sciences
Zip code
115-8650
Address
1-7-11, Akabanedai, Kita-ku, Tokyo
TEL
03-5924-2819
Homepage URL
serizawa@toyo.jp
Sponsor or person
Institute
Toyo University
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
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
Toyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2100, Kujirai, Kawagoe city, Saitama, Japan
Tel
049-239-1440
mlkks@toyo.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
| 2024 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063910
