UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045949 |
|---|---|
| Receipt number | R000052446 |
| Scientific Title | Improving effects of dietary supplements with sake lees on some health conditions of healthy adults |
| Date of disclosure of the study information | 2022/01/11 |
| Last modified on | 2023/05/08 16:25:39 |
* 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
Improving effects of dietary supplements with sake lees on some health conditions of healthy adults
Acronym
Improving effects of dietary supplements with sake lees on some health conditions of healthy adults
Scientific Title
Improving effects of dietary supplements with sake lees on some health conditions of healthy adults
Scientific Title:Acronym
Improving effects of dietary supplements with sake lees on some health conditions of healthy adults
Region
| Japan |
Condition
Condition
Healthy Volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of dietary supplement with sake lees on health conditions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dull skin/clarity
Rough hands
Oily face
Tired eyes
Stiff shoulder
Skin texture
Dry eyes
Defecation frequency
Skin firmness
Foot swelling
Noticeable pores
Stomach discomfort
Sensitivity to cold
Dry skin
Awakening
Frequent pimples
Quality of sleep
Malaise
Spots and freckles
Bowel movement
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Sake lees powder (0.5g dose)
Interventions/Control_2
Sake lees powder (0.1g dose)
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Subjects who are voluntarily giving written informed consent.
2)Healthy volunteers aged between 30 and 65.
Key exclusion criteria
1)Subjects who with a history of serious illness or are under treatment.
2)Pregnant woman.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Tomatsu |
Organization
Akita Research Institute of Food and Brewing
Division name
Food function group
Zip code
010-1623
Address
4-26 Sanuki Arayamachi, Akita
TEL
0188882000
sayaka@arif.pref.akita.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Tomatsu |
Organization
Akita Research Institute of Food and Brewing
Division name
Food function group
Zip code
010-1623
Address
4-26 Sanuki Arayamachi, Akita
TEL
0188882000
Homepage URL
sayaka@arif.pref.akita.jp
Sponsor or person
Institute
Akita Research Institute of Food and Brewing
Institute
Department
Personal name
Funding Source
Organization
Akita Research Institute of Food and Brewing
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Akita Research Institute of Food and Brewing
Address
4-26 Sanuki Arayamachi, Akita
Tel
0188882000
info@arif.pref.akita.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
| 2022 | Year | 01 | Month | 11 | 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
| 2021 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052446
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
