UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056320 |
|---|---|
| Receipt number | R000064355 |
| Scientific Title | Effect of sweetened foods on stress reduction |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2025/02/04 22:54:41 |
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Basic information
Public title
Effect of sweetened foods on stress reduction
Acronym
Effect of sweetened foods on stress reduction
Scientific Title
Effect of sweetened foods on stress reduction
Scientific Title:Acronym
Effect of sweetened foods on stress reduction
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of sweetened foods on stress reduction after stressful experiences.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stress marker (cortisol)
Key secondary outcomes
Serotonin, beta-endorphin, heart rate and skin electrical activity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
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
Sweetened food intake after stress load.
Interventions/Control_2
No sweetened food intake after stress load.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who have given their consent to participate in the research.
Key exclusion criteria
Persons who have a habit of eating the target foodstuff in the period prior to the intervention.
Persons who are allergic to the target foods, have severe hepatic or renal dysfunction, have severe diabetes mellitus, or have a tendency toward severe obesity.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Goryoda |
Organization
Yamagata University
Division name
Faculty of Agriculture
Zip code
997-0037
Address
1-23 Wakaba-cho, Tsuruoka-shi, Yamagata 997-0037
TEL
0235282859
goryoda@tds1.tr.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | goryoda |
Organization
Yamagata University
Division name
Faculty of Agriculture
Zip code
997-0037
Address
1-23 Wakaba-cho, Tsuruoka-shi, Yamagata 997-0037
TEL
0235282859
Homepage URL
goryoda@tds1.tr.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Yamagata University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Healthcare Systems Co., Ltd.
Address
Park Place 5F 5-27-1 Shimbashi, Minato-ku, Tokyo
Tel
03-6809-2722
ishikawa@hc-sys.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 | 11 | Month | 30 | 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
| 2024 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2025 | 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 | 11 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064355
