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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026477
Receipt No. R000030338
Scientific Title Evaluation test on intestinal environment improvement effect by ingesting chocolate
Date of disclosure of the study information 2017/03/10
Last modified on 2017/07/07

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Basic information
Public title Evaluation test on intestinal environment improvement effect by ingesting chocolate
Acronym Evaluation test on intestinal environment improvement effect by ingesting chocolate
Scientific Title Evaluation test on intestinal environment improvement effect by ingesting chocolate
Scientific Title:Acronym Evaluation test on intestinal environment improvement effect by ingesting chocolate
Region
Japan

Condition
Condition Healthy person
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Chocolate effect We aim to clarify the effect of bowel movement improvement and its mechanism of CACAO 72%. For women who are aware of constipation, we will make comparison between groups by taking test food (chocolate effect CACAO 72%) or control food (white chocolate) for about 2 g a day for 2 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Bowel movement (stool frequency, stool volume)
Key secondary outcomes 1) Bowel movements (defecation days, feces)
2) Blood short chain fatty acid concentration (HPLC method)
3) Fecal acid short-chain fatty acid concentration (HPLC method)
4) Faecal bacteria and fecundity in faecal bacteria (qPCR method)
5) Relief of constipation (CAS method; Japanese constipation rating scale)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Test food intake group (5 sheets a day (about 25 g) 2 weeks)
Interventions/Control_2 Control food intake group (6 sheets a day (about 25 g) 2 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
50 years-old >
Gender Female
Key inclusion criteria 1)Those who received a sufficient explanation of the purpose and contents of this exam, who have the capacity to consent, voluntarily volunteer with sufficient understanding, and agree to participate in the document
2)A healthy woman aged 20 years or under and under 50 years old who satisfies the following conditions at screening
(1) Persons whose stool frequency is 4 or less on average per week
Key exclusion criteria Not applicable to any one of the following exclusion criteria.
1) Currently, those who have some type of chronic illness and are undergoing drug treatment
2) Persons who are allergic to chocolate, milk, soybeans
3) Headache induced by ingestion of chocolate
4) Persons with lactose intolerance
5) Those who take cocoa products four times a week or more during the three months before screening
6) Those who take natto at least four times a week for three months before screening
7) Those who ingest lactic acid bacteria-containing foods such as yoghurt, lactic acid bacteria beverages and the like more than four times per week for three months before the screening
8) Persons taking or ingesting medicines such as intestinal medicines, which may affect this test result, quasi-drugs, supplements, health foods, foods for specified health use (Tokuho), functional display foods on a daily basis, Or who intends to take or ingest during the test
9) Those who participated in other clinical trials and monitoring examinations during the month before screening, or who plan to participate in other clinical trials after this clinical trial consent
10) Persons who are pregnant, plan for pregnancy during the study period, those who have hope
11) Who is breastfeeding
12) Alcohol-heavy drinkers (drinkers with a daily average over 60 g in terms of pure alcohol)
13) Others who judged that the investigator is inappropriate as the subject
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maiko Tajima
Organization Beauty & Health Research_Inc
Division name Medical Research Department
Zip code
Address Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan
TEL 03-5354-7388
Email info@b-hr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ai Marume
Organization Beauty & Health Research_Inc
Division name Medical Research Department
Zip code
Address Sankyo Nisisinnjuku Buiding 4F 4-2-18 Nisisinnjuku Shinjuku-ku Tokyo, 160-0023 Japan
TEL 03-5354-7388
Homepage URL http://www.b-hr.jp/
Email marume@b-hr.jp

Sponsor
Institute Beauty & Health Research Inc
Institute
Department

Funding Source
Organization Meiji 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
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 株式会社ビューティアンドヘルスリサーチ(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 10 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 01 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 07 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 03 Month 09 Day
Last modified on
2017 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030338

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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