UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042933 |
|---|---|
| Receipt number | R000049010 |
| Scientific Title | Study of the effect of a test food on feeling of tiredness |
| Date of disclosure of the study information | 2021/01/08 |
| Last modified on | 2021/09/16 13:34:03 |
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Basic information
Public title
Study of the effect of a test food on feeling of tiredness
Acronym
Study of the effect of a test food on feeling of tiredness
Scientific Title
Study of the effect of a test food on feeling of tiredness
Scientific Title:Acronym
Study of the effect of a test food on feeling of tiredness
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to verify the effect on feeling of tiredness when healthy adult males and females who have a feeling of tiredness have a drink containing lactic acid bacteria beverage per day for 12 weeks continuously
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fatigue VAS questionnaire
Key secondary outcomes
sleep VAS questionnaire
POMS2
OSA-MA
intestinal flora (amplicon sequence analysis)
faecal IgAs
Plasma catecholamines 3 fractions
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 12 weeks
Interventions/Control_2
Intake of placebo for 12 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)males and females from 20 to 64 years of age
(2)Subjects who have a feeling of tiredness at the inspection before intervention
(3)Subjects undergoing none of medical treatments
(4)Subjects who have an ability to understand the purpose and contents of this clinical trial and voluntarily applied and agreed to participate in this clinical trial after the explanation of this clinical trial
Key exclusion criteria
Subjects
(1)who take medicines, quasi-drugs, supplements, health foods, etc. more than 3 days a week
(2)who cannot restrict the use of medicine or health foods that may influence their bowel movements after informed consent
(3)visiting the hospital for diseases related to bowel movements and using drugs, or regularly using commercially available constipation medicine
(4)who are under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease)
(5)currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system (except appendicectomy)
(6)with diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement, suspected of these diseases or have a history of these diseases
(7)who drink alcohol over 1500 mL in terms of beer or smoke over average 20 cigarettes per day
(8)who have a lifestyle that affect the result of this clinical trial (such as night shift worker or physical worker that carries heavy objects), or who plan to have such lifestyles during the test period
(9)whose feeling of tiredness is caused by pain or suspected to be induced by pain
(10)who are diagnosed with chronic fatigue syndrome or insomnia, or suspected of these diseases
(11)who are diagnosed with sleep apnea syndrome or are suspected to have it
(12)with a large fluctuation on defecation during menstruation or at poor physical condition
(13)who have allergies to a specific drug or food
(14)who have a feeling of tiredness caused by allergies to pollen, house dust, etc
(15)who have participated in other clinical trial in the past one month, who have a plan to participate in other clinical trial during the test period
(16)who are planned to become pregnant after submission of informed consent for this clinical trial or are pregnant or lactating
(17)who are judged as unsuitable for this clinical trial by the investigator for other reasons
Target sample size
154
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Segawa |
Organization
Nissin York Co., Ltd.
Division name
Development Laboratories
Zip code
348-8549
Address
272, Tsutsumine, Kamimurakimi, Hanyu, Saitama, Japan
TEL
048-565-4686
shuichi.segawa@nissin.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsui |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Clinical Operations Division
Zip code
103-0027
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo, Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Nissin York 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
Kanazawabunko Hospital IRB
Address
2-6-22,Kamariyahigashi,Kanazawa-ku,Yokohama-shi,Kanagawa-ken,Japan
Tel
045-785-3311
h.itou@kanabun-hp.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 | 01 | Month | 08 | 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 | 12 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049010
