UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026477 |
|---|---|
| Receipt number | 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 17:07:02 |
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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
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/
marume@b-hr.jp
Sponsor or person
Institute
Beauty & Health Research Inc
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030338
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
