UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055157 |
|---|---|
| Receipt number | R000063019 |
| Scientific Title | Study on the stress-relieving effects of Sea Buckthorn juice consumption. |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/04/12 16:37:31 |
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Basic information
Public title
Study on the stress-relieving effects of Sea Buckthorn juice consumption.
Acronym
Study on the stress-relieving effects of Sea Buckthorn juice consumption.
Scientific Title
Study on the stress-relieving effects of Sea Buckthorn juice consumption.
Scientific Title:Acronym
Study on the stress-relieving effects of Sea Buckthorn juice consumption.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the stress-relieving effects of the test food, Sage Juice, as well as to evaluate the usefulness and safety of Sage Juice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in stress states using the VAS method.
Key secondary outcomes
POMS2, Brief job Stress Questionnaire (BJSQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Seabuckthorn juice
Interventions/Control_2
Placebo juice
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) People who are temporarily fatigued or have reduced vitality due to desk-based work.
(2) Men and women who can be judged to be healthy by the investigator based on medical examination data within the past three months.
(3) Those with a BMI of less than 30 kg/m2
(4) Persons who can give written voluntary consent to participate in the trial.
(5) Those who are able to drink Seabuckthorn Juice on a continuous basis.
Key exclusion criteria
(1) Persons currently receiving drugs for any disease
(2) Persons who are consuming food or health food containing the ingredients of this test food.
(3) Persons with serious diseases or psychiatric disorders of the glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system (4) Persons with a history of such diseases.
(4) Persons with a history of abnormal laboratory values, which may be considered problematic for participation in the study
(5) Persons with a disease undergoing treatment or with a history of a serious disease requiring medication
(6) Persons at risk of developing allergies related to the study
(7) Persons who are judged to be unsuitable as subjects based on the results of the lifestyle questionnaire
(8) Those who are participating in other clinical studies at the start of the study
(9) Those who are pregnant or plan to become pregnant or breastfeed during the study period
(10) Persons who are deemed unsuitable to participate in the study by the study investigator (or the study manager).
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Takeda |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Welll-being Faculty of Health Science for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-1, Kashiwara-city, Osaka
TEL
072-978-0088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Takeda |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Welll-being Faculty of Health Science for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-1, Kashiwara-city, Osaka
TEL
072-978-0088
Homepage URL
rtakeda@tamateyama.ac.jp
Sponsor or person
Institute
Kansai University of Welfare Sciences
Institute
Department
Personal name
Funding Source
Organization
Finess 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel
027-212-5608
sagawa@mc-connect.co.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 | 12 | Month | 31 | 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 | 05 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 10 | 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 | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063019
