UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051037 |
|---|---|
| Receipt number | R000058072 |
| Scientific Title | Effects of Optimized Nutritional Meals on Sleep, Fatigue and Stress. |
| Date of disclosure of the study information | 2023/05/12 |
| Last modified on | 2024/02/22 15:11:04 |
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Basic information
Public title
Effects of Optimized Nutritional Meals on Sleep, Fatigue and Stress.
Acronym
Effects of Optimized Nutritional Meals on Sleep, Fatigue and Stress.
Scientific Title
Effects of Optimized Nutritional Meals on Sleep, Fatigue and Stress.
Scientific Title:Acronym
Effects of Optimized Nutritional Meals on Sleep, Fatigue and Stress.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to examine the effect of ingesting the test food on stress, mental condition, fatigue and sleep.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes on stress and mental condition
Key secondary outcomes
1. Indexes on fatigue
2. Indexes on sleeping
3. Indexes on quality of life
4. Indexes on eating habit
5. Physical and clinical examinations.
6.Indexes for body composition.
*Safety indexes
1.Doctor's questions
2.Side effects and adverse events
3.Subject's diary
*Other indexes
1.Baseline characteristics
2.Height measurement
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test product (Any one meal of breakfast, lunch or dinner; 4 weeks).
Interventions/Control_2
Oral intake of normal meals (keeping habit of eating before participating with the study; 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 20-59 years
2) Individuals who experience stress and fatigue in their daily lives, or who are prone to feeling stress and fatigue (ex. stress and fatigue due to work, housework).
3) Individuals who are dissatisfied with their sleep quality.
4) Individuals who sleep alone.
5) Individuals who work 5 days a week during the day and have Saturdays and Sundays off.
6) Individuals who have a regular lifestyle on weekdays (ex. wake-up time or bedtime).
7) Individuals whose written informed consent has been obtained.
8) Individuals who can come to the designated venue for this study and be inspected.
9) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes and hyperlipidemia.
3) Individuals who have or have a history of sleep apnea syndrome (SAS)
4) Individuals whose BMI is over 25.0kg/m2.
5) Individuals who used a drug to treat a disease in the past 1 month.
6) Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease and hematological disease.
7) Individuals who are a patient or have a history of or gastrointestinal disease.
8) Individuals who have or may have food allergic symptoms.
9) Individuals who cannot continue to eat a test meal
10) Individuals whose eating habit for breakfast, lunch, and dinner is irregular and has an unbalanced diet.
11) Individuals who have frequent alcohol intake habits (individuals who have difficulty abstaining from alcohol during the home survey period).
12) Individuals who have an environment that disturbs sleep at bedtime (ex. infants or pets).
13) Individuals with possible changes of lifestyle, such as conducting a long-term travel, during the test period.
14) Individuals whose sleeping conditions may be different during the period of electroencephalogram measurement (ex. overnight stay).
15) Individuals who are or are possibly pregnant, or are lactating.
16) Individuals who have or had a habit to ingest health-promoting foods, foods for specified health uses, or health foods in the past 3 months, or will ingest those foods during the test period.
17) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
18) Individuals who have difficulty conducting tests using mobile applications.
19) Individuals who participated in other clinical studies in the past 3 months.
20) Individuals who are or whose family is engaged in health foods of functional foods.
21) Individuals judged inappropriate for the study by the principal.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Nakamura |
Organization
NISSIN FOODS HOLDINGS CO., LTD.
Division name
Future Food Research & Development Division
Zip code
192-0001
Address
2100 Tobukimachi, Hachioji-shi, Tokyo
TEL
+81-42-696-7606
futoshi.nakamura@nissin.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
NISSIN FOOD PRODUCTS CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
NISSIN FOOD PRODUCTS 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.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 | 05 | Month | 12 | 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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058072
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