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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036092
Receipt No. R000041117
Scientific Title Effect of Daily Intake of AU-1705 on Intestinal Environment : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Date of disclosure of the study information 2019/03/06
Last modified on 2019/03/05

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Basic information
Public title Effect of Daily Intake of AU-1705 on Intestinal Environment : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Acronym Beneficial Effects of AU-1705 on Intestinal Environment
Scientific Title Effect of Daily Intake of AU-1705 on Intestinal Environment : A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Scientific Title:Acronym Beneficial Effects of AU-1705 on Intestinal Environment
Region
Japan

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

Objectives
Narrative objectives1 To prove the effect of AU-1705 on intestinal environment associated with 4 week daily intake in a randomized, double-blind, placebo-controlled, parallel group study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Gut microbiota diversity at 4 weeks after beginning the intake of test food.
Key secondary outcomes Blood BDNF, blood catecholamine, IFN-gamma, fecal mucin, the Japanese version of constipation assessment scale MT version (CAS-MT), self-rating depression scale (SDS), VAS questionnaire.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Daily intake of 3 capsules containing low-dose of AU-1705 for 4 weeks.
Interventions/Control_2 Daily intake of 3 capsules containing high-dose of AU-1705 for 4 weeks.
Interventions/Control_3 Daily intake of 3 capsules containing dextrin for 4 weeks.
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. Subjects who agree to participate in this study with a written informed consent.
2. Subjects with feeling mental fatigue daily.
3. Subjects who show relatively low Shannon diversity index.
Key exclusion criteria 1. Subjects who are under physician's advice, treatment, and/or medication for schizophrenia, depression, mania, neurological disorders, and/or sleep disorders.
2. Subjects with a clinical history of gastrointestinal cancer or currently under treatment or anti-tumor medication.
3. Subjects with gastrointestinal disorders such as inflammatory bowel syndrome, irritable bowel syndrome, etc.
4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data.
7. Subjects with severe anemia.
8. Pre- or post-menopausal women complaining of obvious physical changes.
9. Subjects who are at risk of having allergic reactions to drugs or foods, especially gelatin and/or soybean.
10. Subjects who regularly take medicine, functional foods, and/or supplements which would affect intestinal environment.
11. Subjects who have used as needed or continued to use antibiotics within 4 weeks prior to screening test.
12. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
13. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
14. Pregnant or lactating women or women who expect to be pregnant during this study.
15. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
16. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Health Information Science Research Center
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Amino Up Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道情報大学 保健センター(北海道)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 06 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 25 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
2019 Year 03 Month 05 Day
Last modified on
2019 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041117

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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