UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052951 |
|---|---|
| Receipt number | R000060417 |
| Scientific Title | Study of the effects of tomato smoothie intake on stress |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2024/06/03 16:50:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the effects of tomato smoothie intake on stress
Acronym
Study of the effects of tomato smoothie intake on stress
Scientific Title
Study of the effects of tomato smoothie intake on stress
Scientific Title:Acronym
Study of the effects of tomato smoothie intake on stress
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of tomato smoothie intake for 4 weeks on stress and the changes of physical and psychological conditions of healthy subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary stress biomarkers
Key secondary outcomes
Autonomic nervous system
Skin moisture content and TEWL(trans epidermal water loss)
POMS2
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
Intake of tomato smoothie of 180mlx 2 bottles/day for 4 weeks
Interventions/Control_2
Non-intake of tomato smoothie for 4 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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects between the ages of 20 and 70(excluding smokers) at the time of written consent.
2. Subjects who have given written informed consent after receiving a thorough explanation of the study.
Key exclusion criteria
1.Those who cannot secure sufficient saliva volume due to saliva collection.
2.Those who may develop allergy to vegetables.
3.Those who are deemed inappropriate as research subjects by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Mizushima |
Organization
Juntendo University Graduate School of Medicine
Division name
Palliative Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
akiom@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Akio |
| Middle name | |
| Last name | Mizushima |
Organization
Juntendo University Graduate school of Medicine
Division name
Palliative Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
akiom@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee Faculty of Medicine, Juntendo University
Address
3-1-3 HongoBunkyo-ku Tokyo Japan
Tel
03-5802-1584
hongo-rinri@juntendo.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
| 2023 | Year | 12 | Month | 01 | 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
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060417
