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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036704
Receipt No. R000041790
Scientific Title Examination of influence on stress and fatigue in continuous intake of test food
Date of disclosure of the study information 2019/05/17
Last modified on 2019/05/28

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Basic information
Public title Examination of influence on stress and fatigue in continuous intake of test food
Acronym Examination of influence on stress and fatigue in continuous intake of test food
Scientific Title Examination of influence on stress and fatigue in continuous intake of test food
Scientific Title:Acronym Examination of influence on stress and fatigue in continuous intake of test food
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to investigate the effect of the Examine the effects on fatigue and stress in men and women aged 20 years or older, 60 years or younger, who have received the continuously for 4 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes POMS2 shorter version
Key secondary outcomes VAS questionnaire,Pittsburgh Sleep Quality Index,Cortisol (saliva), chromogranin A (saliva)

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 4-week intake of the test food
Interventions/Control_2 4-week intake of the placebo food
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 male and female aged between 20 and 60 years old at the time of the informed.
2)Subject who feels fatigue and stress routinely.
3)Subject who fatigues score (FI-T score) of POMS 2 abbreviated version is 50 points or more.
4)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria 1)Subject who is taking medication or under medical treatment.
2)Subject who is under exercise therapy or dietetic therapy.
3)Subject who has an allergy for test food.
4)Subject who has or had a history of either medicine or alcohol dependence syndrome.
5)Subject who has or had a history of mental illness (depression) or sleep disturbance.
6)Subject who is on a night-shift or is a shift worker.
7)Subject whose lifestyle is extremely irregular.
8)Subject who has an unbalanced diet.
9)Subject who has current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases.
10)Subjects who has taken health foods, supplements, or drugs that may affect fatigue relief.
11)Subject who has routinely taken large amounts of drinks containing a lot of caffeine (equivalent to 7 cups of coffee / day or more).
12)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study.
13)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition.
14)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating.
15)Subject who is expected to have major changes or stress in their own home environment or work environment from one month before screening to the end of the exam (job change, move, marriage, etc.).
16)Subject who gets intense exercise every day.
17)Subject who smokes regularly om a daily(more than 20 cigarettes per day).
18)Subject who can't keep the daily records.
19)Subject who is judged as an inappropriate candidate according to the screening data.
20)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name toshimasa
Middle name
Last name higuchi
Organization ASAHI SOFT DRINKS CORP
Division name Product Development Laboratory
Zip code 302-0106
Address 1-1-21 Midori, Ibaraki Prefecture
TEL 0297-46-9935
Email toshimasa.higuchi@asahiinryo.co.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Ochitani
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code 108-0014
Address Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL 03-3431-1260
Homepage URL
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

Funding Source
Organization Asahi Beverage 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 Ethics Committees of Nihonbashi Egawa Clinic
Address 2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel 03-5204-0311
Email jim@medipharma.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
2019 Year 05 Month 17 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 No longer recruiting
Date of protocol fixation
2019 Year 03 Month 04 Day
Date of IRB
2019 Year 03 Month 11 Day
Anticipated trial start date
2019 Year 04 Month 25 Day
Last follow-up date
2019 Year 06 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 10 Day
Last modified on
2019 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041790

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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