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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045949
Receipt No. 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 2021/11/15

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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
Email 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
Email sayaka@arif.pref.akita.jp

Sponsor
Institute Akita Research Institute of Food and Brewing
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 11 Month 15 Day
Date of IRB
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
2021 Year 11 Month 15 Day


Link to view the page
URL(English) 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


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