UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052184 |
|---|---|
| Receipt number | R000058759 |
| Scientific Title | Investigation of the effects of continuous intake of test food on mental and physical condition |
| Date of disclosure of the study information | 2023/10/02 |
| Last modified on | 2026/04/06 18:30:58 |
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Basic information
Public title
Investigation of the effects of continuous intake of test food on mental and physical condition
Acronym
Investigation of the effects of continuous intake of test food on mental and physical condition
Scientific Title
Investigation of the effects of continuous intake of test food on mental and physical condition
Scientific Title:Acronym
Investigation of the effects of continuous intake of test food on mental and physical condition
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food intake on mental and physical conditions under stress
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation by questionnaire on sleep
Key secondary outcomes
Evaluation by questionnaire on stress
Evaluation by questionnaire on quality of life
Saliva test (stress indicators)
Urine test (stress indicators)
Evaluation of autonomic activity
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
Intake of test food for 8 weeks
Interventions/Control_2
Intake of placebo food for 8 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy 4th year students at the University of Tokushima Faculty of Medicine
2. Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the present study and being able to sign a written informed consent
Key exclusion criteria
1. Subjects who have a disease and go to a hospital or undergoing treatment
2. Subjects taking medication regularly during the experimental period
3. Subjects who smoke
4. Subjects with milk allergies
5. Subjects who are pregnant, or who plan or wish to become pregnant during the examination period
6. Subjects who participated in other clinical trials in one month or who plan to participate in other clinical trials during the examination period
7. Subjects deemed unsuitable for the present study by the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kensei |
| Middle name | |
| Last name | Nishida |
Organization
Tokushima University
Division name
Inst. of Biomedical Sciences, Tokushima University Graduate School
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9104
knishida@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kensei |
| Middle name | |
| Last name | Nishida |
Organization
Tokushima University
Division name
Inst. of Biomedical Sciences, Tokushima University Graduate School
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
088-633-9104
Homepage URL
knishida@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima, JAPAN
Tel
088-633-8512
first-ec@tokushima-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0022030226000998?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0022030226000998?via%3Dihub
Number of participants that the trial has enrolled
78
Results
In the per-protocol set, the test food group showed significant improvement in OSA-MA Factor I (morning sleepiness) at 2 and 4 weeks compared with the placebo group. Fitbit data also showed increased sleep duration at 4 and 5 weeks. In contrast, in the placebo group, OSA-MA Factors I and V (sleep duration) worsened at 4 and 7 weeks, whereas the test food group remained stable. These findings suggest maintenance of sleep homeostasis under psychological stress.
Results date posted
| 2026 | Year | 04 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants: Healthy Japanese fourth-year medical students (aged 21-29 years)
Randomization: 78 participants assigned to OLL2716 or placebo groups
PPS population: 55 participants (OLL2716: n=23; placebo: n=32)
Sex: OLL2716: 7 females, 16 males; Placebo: 11 females, 21 males
Age: 22.7+/-1.8 vs 22.3+/-1.1 years
BMI: 21.3+/-3.2 vs 21.7+/-2.7 kg/m2
No significant differences between groups in baseline sleep indices (OSA-MA, PSQI, Fitbit) or primary outcomes
No participants diagnosed with sleep disorders during the study
Participant flow
Enrolled: 78 participants
Randomized: 78 (39 per group)
Dropouts: 5 (OLL2716: 2; placebo: 3; disqualified from exams)
Completed: 73
Excluded from FAS: 1 (met exclusion criteria)
Excluded from PPS: 17
<70% intake: 9
Use of medications/functional foods: 8
Final PPS analysis: 55 participants
Adverse events
No adverse events related to the test food intake were reported
Outcome measures
Primary outcomes
Subjective sleep quality
OSA-MA (Ogri-Shirakawa-Azumi sleep inventory MA version)
PSQI (Pittsburgh Sleep Quality Index)
Secondary outcomes
Objective sleep (Fitbit): Total sleep time, light sleep, deep sleep, REM sleep, sleep latency
Anxiety: STAI (State-Trait Anxiety Inventory)
Stress biomarkers: Salivary cortisol, Salivary chromogranin A
Oxidative stress marker: Urinary biopyrrins
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 02 | 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
Among the outcomes registered in the UMIN-CTR, the quality-of-life (QOL) questionnaire was not administered to reduce participant burden. Therefore, no results are available for this outcome.
Management information
Registered date
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058759
