UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028717 |
|---|---|
| Receipt number | R000032868 |
| Scientific Title | A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions. A randomized, double-blind, placebo- controlled trial. |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2017/12/10 22:22:29 |
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Basic information
Public title
A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions. A randomized, double-blind, placebo- controlled trial.
Acronym
A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions.
Scientific Title
A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions. A randomized, double-blind, placebo- controlled trial.
Scientific Title:Acronym
A study for evaluating the effects of oral intake of food originated from a microorganism on fatigue and immune functions.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of oral intake of food originated from a microorganism on fatigue and immune functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue and stress indices (subjective indices)
Key secondary outcomes
Fatigue and stress indices (objective indices), immune indices (subjective indices)
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
Food originated from a microorganism, 1 portion of food per day for 14 days.
Interventions/Control_2
Placebo food, 1 portion of food per day for 14 days.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Healthy individuals aged more than 18 years old, when giving the informed consent.
2)Individuals who are received enough explanation of the purpose and the details of this study, who decided to attend this study with their own will, who have ability of agreement, and who submitted the informed consents in writing.
Key exclusion criteria
1)Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
2)Individuals who have chronic diseases and use medicines continuously.
3)Individuals who need the application of medicine containing steroids.
4)Individuals who are seropositive against HBV antigen, HCV antibody, HIV antibody, or HTLV-1 antibody.
5)Individuals who cannot stop eating foods containing ingredients similar to test foods.
6)Individuals who cannot stop eating functional foods which may affect immune functions.
7)Individuals with excessive alcohol-drinking behaviors.
8)Individuals who cannot stop drinking for 2 days before the days of checkup.
9)Individuals who have a medical history of diseases affecting digestion and absorption.
10)Individuals who have a history of inflammatory bowel disease and irritable bowel syndrome.
11)Individuals who are judged as unsuitable for this study based on the results of blood test.
12)Individuals who have under treatment or a history of drug addiction and/or alcoholism.
13)Individuals who are participating or willing to participate in other clinical trials.
14)Individuals whose family works for a company manufacturing or selling healthy foods or functional foods.
15)Individuals who cannot sleep at night due to the irregular work-shift or other reasons.
16)Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kosuke Fukao |
Organization
Juntendo University School of Health and Sports Science
Division name
Department of Sports Medicine (internal medicine)
Zip code
Address
1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL
0476-98-1001
fukao777@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Fukao |
Organization
Juntendo University School of Health and Sports Science
Division name
Department of Sports Medicine (internal medicine)
Zip code
Address
1-1 Hirakagakuendai, Inzai, Chiba, Japan
TEL
0476-98-1001
Homepage URL
fukao777@juntendo.ac.jp
Sponsor or person
Institute
Department of Sports Medicine (internal medicine), Juntendo University School of Health and Sports Science
Institute
Department
Personal name
Funding Source
Organization
Kirin Company, Limited
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
Address
Tel
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
順天堂大学スポーツ健康科学部／Juntendo University School of Health and Sports Science
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
| 2017 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032868
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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