UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041751 |
|---|---|
| Receipt number | R000047653 |
| Scientific Title | Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake |
| Date of disclosure of the study information | 2021/12/18 |
| Last modified on | 2021/03/31 15:26:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake
Acronym
Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake
Scientific Title
Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake
Scientific Title:Acronym
Research on healthy adult men and women who are tired, diminished in vitality, and dissatisfied with sleep quality in daily life of improvement effect by food intake
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of subject food intake for 8 consecutive weeks on the subjective evaluation of fatigue, vitality, and sleep, using placebo as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS2 T-score and OSA-MA at before, 4 and 8 weeks
Key secondary outcomes
SF36 at before, 4 and 8 weeks and flulike symptoms score during intake period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
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 daily intake, for 8 weeks
Interventions/Control_2
Intake of placebo daily intake, 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Men and women between 20 and 64 years of age.
(2) Subjects who feel fatigued and less active
(3) Subjects with poor sleep quality
Key exclusion criteria
(1) Subjects who regularly use health foods containing the ingredients involved in the test food
(2) Subjects engaged in actions/drugs or health food use to improve fatigue, stress, or sleep.
(3) Subjects with a disease undergoing treatment or with a disease determined to be in need of treatment.
(4) Subjects who have, have been diagnosed with, or are strongly suspected of having a sleep-related illness.
(5) Subjects with a previous diagnosis of chronic fatigue syndrome
(6) Subjects who are being treated for or have a history of mental illness, or are suspected to be suffering from one.
(7) Seriously ill subjects and subjects with a history of serious illness
(8) Subjects with irregular working days (holidays)
(9) Subjects whose lives will become irregular more than once during the research period due to day/night shift work or night work, or who are engaged in physical labor such as heavy lifting.
(10) Subjects with major life changes planned during the study period.
(11) Subjects who have allergic diseases and are constantly taking therapeutic medication.
(12) Subjects with diarrhea
(13) Subjects with less than 3 bowel movements per week.
(14) Subjects who are pregnant or lactating and who plan to become pregnant or breastfeeding during the study period.
(15) Subjects at risk of developing allergies in connection with the study.
(16) Subjects whose physical measurements, physical examination values, and clinical examination values at the pre-examination are significantly outside the reference range.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | To |
Organization
Kenkoukazoku Co., Ltd.
Division name
None
Zip code
892-0848
Address
10-2, Hirano-cho, Kagoshima-shi, Kagoshima, 892-0848, JAPAN
TEL
099-223-5211
yasushi.nakasone@kenkoukazoku.co.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Nakasone |
Organization
Kenkoukazoku Co., Ltd.
Division name
None
Zip code
892-0848
Address
10-2, Hirano-cho, Kagoshima-shi, Kagoshima, 892-0848, JAPAN
TEL
099-223-5211
Homepage URL
yasushi.nakasone@kenkoukazoku.co.jp
Sponsor or person
Institute
TTC Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Kenkoukazoku 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
t.saito@ttc-smo.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
| 2021 | Year | 12 | 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
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
| 2020 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 10 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047653
