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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042933
Receipt No. 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 2021/01/12

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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
Email 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
Email food-contact@apoplus.co.jp

Sponsor
Institute APO PLUS STATION CO., LTD.
Institute
Department

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
Email 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 Open public recruiting
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 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049010

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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