UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023188
Receipt No. R000026323
Scientific Title Effects of ingestion of cookies containing Jerusalem artichoke on improving constipation of healthy high school students.
Date of disclosure of the study information 2016/07/20
Last modified on 2017/03/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effects of ingestion of cookies containing Jerusalem artichoke on improving constipation of healthy high school students.
Acronym Effects of ingestion of cookies containing Jerusalem artichoke on improving constipation.
Scientific Title Effects of ingestion of cookies containing Jerusalem artichoke on improving constipation of healthy high school students.
Scientific Title:Acronym Effects of ingestion of cookies containing Jerusalem artichoke on improving constipation.
Region
Japan

Condition
Condition High school students with a tendency for constipation
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of consecutive ingestion of cookies containig Jerusalem artichoke on improving constipation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation days,defecation frequency,fecal amount
Key secondary outcomes Fecal shape,fecal color,fecal odor,feeling after defecation

Base
Study type Interventional

Study design
Basic design Cross-over
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 The subjects ingested the placebo meal for two weeks, after 7 days, ingested the active food for two weeks.
Interventions/Control_2 The subjects ingested the active meal for two weeks, after 7 days, ingested the placebo food for two 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
16 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria 1) Second and third year students in Nagasaki-Minami high school
2) Subjects who can refrain from gluttony during the test period
3) Individuals who understand the purpose and contents of the experiment
4) Subjects giving written informed concent
Key exclusion criteria 1)Individuals taking drugs which affect the bowel movement.
2)Subjects who can't refrain from supplements and healthy foods which affect the bowel movement during the test period
3)Subjects who are contracting or treating kidney and/or liver diseases.
4)Individuals with a chronic diseases.
5)Individuals participating or intending to participate in a drug administration test.
6)Individuals judged by the doctor to be unsuitable.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunari Tanaka
Organization Univercity of Nagasaki
Division name Faculty of Nursing and Nutrition
Zip code
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 095-813-5216
Email katanaka@sun.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Ito
Organization Univercity of Nagasaki
Division name Faculty of Nursing and Nutrition
Zip code
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 095-813-5500
Homepage URL
Email katanaka@sun.ac.jp

Sponsor
Institute Univercity of Nagasaki
Faculty of Nursing and Nutrition
Institute
Department

Funding Source
Organization Nagasaki-Minami high school
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 長崎南高等学校

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 20 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
2016 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 12 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 15 Day
Last modified on
2017 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026323

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.