UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061109 |
|---|---|
| Receipt number | R000069907 |
| Scientific Title | Preliminary study on the effects of a lactic acid drink on cognitive performance, sleep, fatigue, and gastrointestinal symptoms. |
| Date of disclosure of the study information | 2026/04/06 |
| Last modified on | 2026/03/28 20:41:49 |
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Basic information
Public title
Preliminary study on the effects of a lactic acid drink on cognitive performance, sleep, fatigue, and gastrointestinal symptoms.
Acronym
Lactic acid drink at Sado-Island
Scientific Title
Preliminary study on the effects of a lactic acid drink on cognitive performance, sleep, fatigue, and gastrointestinal symptoms.
Scientific Title:Acronym
Lactic acid drink at Sado-Island
Region
| Japan |
Condition
Condition
Subjective sleep problems
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of daily intake of a lactic acid drink on sleep and related cognitive performance in older adults, and to exploratorily assess perceived fatigue and gastrointestinal symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Psychomotor vigilance task (PVT)
Key secondary outcomes
Digit Symbol Substitution Test (DSST), Fatigue level (VAS), Pittsburg Sleep Questionnaire Index (PSQI), Gastrointestinal Symptom Rating Scale (GSRS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will consume 100 mL of a lactic acid drink daily for 12 weeks.
Interventions/Control_2
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who are able to attend the regularly scheduled measurement sessions.
(2) Individuals aged 60 years or older at the time of informed consent.
(3) Individuals who perceive that they have sleep problems, such as difficulty falling asleep after going to bed, shallow sleep, or frequent awakenings during the night.
(4) Individuals who have the capacity to provide consent, have received a sufficient explanation of the purpose and procedures of the study, fully understand the information provided, and voluntarily agree to participate by signing the written informed consent form.
Key exclusion criteria
(1) Individuals who have participated in another clinical study within the past three months prior to providing informed consent.
(2) Individuals who habitually consume yogurt or lactic acid drinks four or more days per week.
(3) Individuals with allergies to milk or soy.
(4) Individuals currently undergoing treatment for diabetes.
(5) Individuals who are otherwise judged to be ineligible by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Institute of Social Epidemiology
Zip code
791--0243
Address
Hiraimachi 1383-2, Matsuyama, Ehime
TEL
0899047811
tetsu.prospective@gmail.com
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd
Division name
Institute of Social Epidemiology
Zip code
791--0243
Address
Hiramimachi 1383-2, Matsuyama, Ehime
TEL
0899047811
Homepage URL
tetsu.prospective@gmail.com
Sponsor or person
Institute
Institute of Community Life Sciences Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Soft Drinks 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
Institutional Review Board (IRB) of Sado General Hospital
Address
161 Chigusa, Sado, Niigata 952-1209, Japan
Tel
0259-63-3121
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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
| 2026 | Year | 04 | Month | 06 | 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
| 2026 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 10 | 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
| 2026 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069907
