UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058315 |
|---|---|
| Receipt number | R000066669 |
| Scientific Title | Effects of a dairy ingredient on reducing fatigue sensation: a randomized, double-blind, placebo-controlled trial. |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/06/30 11:26:34 |
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Basic information
Public title
Effects of a dairy ingredient on reducing fatigue sensation: a randomized, double-blind, placebo-controlled trial.
Acronym
Effects of a dairy ingredient on reducing fatigue sensation
Scientific Title
Effects of a dairy ingredient on reducing fatigue sensation: a randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym
Effects of a dairy ingredient on reducing fatigue sensation
Region
| Japan |
Condition
Condition
None (Healthy individuals)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether intake of a dairy ingredient reduces temporary fatigue sensation in daily life among healthy individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue sensation: Visual Analogue Scale (VAS) value
Key secondary outcomes
OSA sleep inventory MA version score; Swelling sensation (VAS value); Cold sensation (VAS value); Eye fatigue sensation (VAS value); Lower back discomfort (VAS value)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Dairy ingredient ingestion for 4 weeks
Interventions/Control_2
Placebo ingestion for 4 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy individuals aged 18-59 years.
Key exclusion criteria
1)Smokers
2)Extremely heavy drinkers (more than 60 g/day of alcohol).
3)Individuals with a persistent or recurrent capacity reduction in conducting daily activities, accompanied by severe fatigue for more than six months.
4)Individuals undergoing treatments for mental and sleep disorders, or chronic fatigue syndrome as well as those with a history of the aforementioned conditions.
5)Individuals exhibiting a serious liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, metabolic system disease as well as those with a chronic disease or serious medical history of the above-described conditions.
6)Individuals displaying a severe food (e.g., milk) or medication allergy as well as those with a significant history of such severe allergies.
7)Pregnant and lactating individuals, or those who expected to be pregnant during the study.
8)Others considered ineligible as research participants in this study, by the principal researcher/doctor based on their background.
Target sample size
132
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Koikeda |
Organization
Shiba Palace Clinic
Division name
Hospital director
Zip code
105-0013
Address
6F Daiwa A Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1599
jimukyoku@mail.souken-r.com
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN Co., Ltd.
Division name
Secretariat
Zip code
105-0013
Address
3F Daiwa A Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1555
Homepage URL
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Shiba Palace Clinic Ethics Review Committee
Address
6F Daiwa A Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1599
jimukyoku@mail.souken-r.com
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
| 2025 | Year | 06 | Month | 30 | 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
| 2025 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 06 | Month | 30 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066669
