UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050642 |
|---|---|
| Receipt number | R000057698 |
| Scientific Title | Effect of Sage Juice Consumption on Mineral Absorption - The Pilot Study |
| Date of disclosure of the study information | 2024/03/20 |
| Last modified on | 2023/09/05 10:28:59 |
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Basic information
Public title
Effect of Sage Juice Consumption on Mineral Absorption - The Pilot Study
Acronym
Effect of Sage Juice Consumption on Mineral Absorption - The Pilot Study
Scientific Title
Effect of Sage Juice Consumption on Mineral Absorption - The Pilot Study
Scientific Title:Acronym
Effect of Sage Juice Consumption on Mineral Absorption - The Pilot Study
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A preliminary study will be conducted to confirm the effect of the test food, Sage Juice, on promoting the absorption of minerals from the diet.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary mineral discharge (creatinine corrected)
Key secondary outcomes
Blood ferritin, red blood cells, serum iron, serum zinc, serum copper, hematocrit, UIBC, TIBC, MCH, MCHC
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
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
Saji 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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1) A person who does not suffer from any disease
(2) Males between the ages of 20 and 50
(3) BMI less than 30 kg/m2
(4) Persons who give written voluntary consent to participate in the study
(5) Who are able to drink SurgiJuice on a continuous basis
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 foods or health foods containing the active ingredients of the food under study.
(4) Persons with serious diseases or psychiatric disorders of glucose metabolism, lipid metabolism, liver function, renal function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system and those with a history of such diseases
(5) Persons with a history of abnormal laboratory values that would be considered problematic for study participation
(6) Persons who have a disease under treatment or a history of a serious disease that required medication
(7) Persons who may develop allergies related to the study
(8) Subjects who are judged to be unsuitable as subjects based on the results of the lifestyle questionnaire
(9) Subjects who are participating in other clinical studies at the time this study is initiated.
(10) Persons who are judged by the investigator (or study administrator) to be unsuitable to participate in the study.
Target sample size
6
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-, Kashiwara-city, Osaka, Japan
TEL
072-978-0088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Shigenori |
| Middle name | |
| Last name | Nibun |
Organization
EAS inc.
Division name
Clinical Trial Session
Zip code
236-0028
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
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
| 2024 | Year | 03 | Month | 20 | 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
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because the data is being processed.
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
| 2023 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 05 | 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
| 2023 | Year | 03 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057698
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
