UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048729 |
|---|---|
| Receipt number | R000055518 |
| Scientific Title | Effects of Sage Juice Consumption on Anti-Fatigue and Q0L in Women |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2024/03/25 16:21:56 |
* 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
Effects of Sage Juice Consumption on Anti-Fatigue and Q0L in Women
Acronym
Effects of Sage Juice Consumption on Anti-Fatigue and Q0L in Women
Scientific Title
Effects of Sage Juice Consumption on Anti-Fatigue and Q0L in Women
Scientific Title:Acronym
Effects of Sage Juice Consumption on Anti-Fatigue and Q0L in Women
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Check anti-fatigue and quality of life with saji drink intake.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL Questionnaire for Daily Life
Key secondary outcomes
Blood test related to anemia, temporary fatigue when performing work tasks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
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
Intake of Saji juice
Interventions/Control_2
Intake of 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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Those who are temporarily fatigued or have low vitality due to a desk-bound job
(2) Premenopausal women between the ages of 20 and 50
(3) BMI less than 30 kg/m2
(4) Those with relatively stable menstrual cycles
(5) Persons who give written voluntary consent to participate in the study
(6) Those who can continue to drink SajiJuice
Key exclusion criteria
(1) Those who are currently under medication for iron deficiency anemia
(2) Those who are currently receiving medication for some disease.
(3) Those who are consuming food products containing the ingredients of this test food or health food products.
(4) Subjects with irregular menstruation
(5) Persons with serious diseases of glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system or psychiatric disorders. (6) Persons with a history of such diseases
(6) Persons with a history of abnormal clinical laboratory values that would be considered problematic for study participation
(7) Persons who have a disease under treatment or a history of a serious disease that required medication
(8) Persons who may develop allergies related to the study
(9) Persons who are judged to be unsuitable as subjects based on the results of the lifestyle questionnaire
(10) Subjects who are participating in other clinical studies at the time this study is initiated.
(11) Pregnant or planning to become pregnant or breastfeeding during the study period
(12) Persons who are judged to be unsuitable to participate in the study by the investigator (or study administrator).
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeda |
| Middle name | |
| Last name | Ryuji |
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-, Kashiwara-city, Osaka, Japan
TEL
072-978-0088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Nibun |
| Middle name | |
| Last name | Shigenori |
Organization
EAS inc.
Division name
Clinical Trial Session
Zip code
239-0028
Address
Susaki-Cho1-10-2F, Kanazawa-ku, Yokohama city, Kanagawa
TEL
045-374-3392
Homepage URL
info@eas-ct.jp
Sponsor or person
Institute
Finess Co, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Finess Co, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KOBUNA ORTHOPEDIC SURGERY
Address
311-2, Gokan-machi, Maebashi, Gunma
Tel
027-261-7600
info@kobunaseikei.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 | 08 | 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
62
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the fact that the results of the analysis are under scrutiny.
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
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 08 | Month | 23 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055518
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
