UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049551 |
|---|---|
| Receipt number | R000056148 |
| Scientific Title | Evaluation of the effect of kefir on sleep quality and gut microbiome in healthy subjects: A randomized, placebo-controlled, double-blind, parallel study |
| Date of disclosure of the study information | 2022/11/18 |
| Last modified on | 2024/11/19 11:13:42 |
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Basic information
Public title
Evaluation of the effect of kefir on sleep quality and gut microbiome in healthy subjects
Acronym
Evaluation of the effect of kefir on sleep quality and gut microbiome in healthy subjects
Scientific Title
Evaluation of the effect of kefir on sleep quality and gut microbiome in healthy subjects: A randomized, placebo-controlled, double-blind, parallel study
Scientific Title:Acronym
Evaluation of the effect of kefir on sleep quality and gut microbiome in healthy subjects: A randomized, placebo-controlled, double-blind, parallel study
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of kefir on sleep quality and gut microbiome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
12-week change in Pittsburg Sleep Quality Index
Key secondary outcomes
12-week changes in the followings: the gut microbiome, Visual Analogue Scale (sleep quality, mental stress, physical fatigue), OSA-Sleep Inventory MA Version, State-Trait Anxiety Inventory, salivary cortisol, and natural stool frequency
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
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects take 1.5 g of powder per day containing 1.0 g of kefir for 12 weeks.
Interventions/Control_2
Subjects take 1.5 g of powder per day containing 0.4 g of kefir for 12 weeks.
Interventions/Control_3
Subjects take 1.5 g of placebo powder per day for 12 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy
2) Constantly feeling unsatisfaction with sleep quality
Key exclusion criteria
1) With a disorder requiring prompt treatment
2) Taking medicines or dietary supplements that may affect the trial
3) Participation in any clinical trial within three months of the commencement of the trial
4) In pregnancy or nursing a child
5) Judged as ineligible by the investigators
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1909
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL
082-257-1909
Homepage URL
healthy-life@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Nihon kefir 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 for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima 734-8551
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.ac.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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 18 | 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
75
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2024 | 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
| 2022 | Year | 11 | Month | 18 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056148
