UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049960 |
|---|---|
| Receipt number | R000046569 |
| Scientific Title | Exploratory study to assess the efficacy of improving the intestinal environment by ingestion of chocolate |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2023/03/27 09:20:39 |
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Basic information
Public title
Exploratory study to assess the efficacy of improving the intestinal environment by ingestion of chocolate
Acronym
Exploratory study to assess the efficacy of improving the intestinal environment by ingestion of chocolate
Scientific Title
Exploratory study to assess the efficacy of improving the intestinal environment by ingestion of chocolate
Scientific Title:Acronym
Exploratory study to assess the efficacy of improving the intestinal environment by ingestion of chocolate
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect on improving constipation by the administration of dark chocolate for 2 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency, fecal condition, amount of defecation, gut microbiota
Key secondary outcomes
Defecation days
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
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
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) Subjects who have received sufficient explanation about the purpose and contents of this study, have the ability to consent, fully volunteered with voluntary intention, agreed to participate in the document
2) Subjects who are healthy females with defecation frequency 4 times or less per week
Key exclusion criteria
1) Subjects who treatment by other doctors
2) Subjects who are allergic to chocolate, milk or soybean
3) Subjects who have headache by ingestion of chocolate
4) Subjects who have lactose intolerance
5) Subjects who take cocoa products four times a week or more during the three months before screening
6) Subjects who take natto four times a week or more during the three months before screening
7) Subjects who take food containing lactic acid bacteria such as yogurt, lactic acid bacteria beverage and four times a week or more during the three months before screening
8) Subjects who routinely use pharmaceuticals quasi-drugs, dietary supplements, health food products and FOSHU or during this study period
9) Subjects who had participated in other clinical trials within 1 month before screening, or plan to participate another study during this study
10) Subjects who are pregnant or planning to become pregnant
11) Subjects who are breast-feeding
12) Subjects who are heavy drinkers with daily average over 60 g in terms of pure alcohol
13) Subjects who are judged unsuitable for this study by investigator or doctor
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ikuko |
| Middle name | |
| Last name | Kimura |
Organization
Medical Corporation Shokyukai Association
Division name
Nishi Shinjuku Hospital Tsubasa Clinic
Zip code
160-0023
Address
Sankyo Nishi-Shinjuku Building 2F, 4-2-18, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5334-6836
info@b-hr.jp
Public contact
Name of contact person
| 1st name | Yoshitoshi |
| Middle name | |
| Last name | Yamada |
Organization
Beauty & Health Research Inc.
Division name
Sales department
Zip code
160-0023
Address
Sankyo Nishi-Shinjuku Building 4F, 4-2-18, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-5354-7388
Homepage URL
yamada@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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji Institutional Review Board
Address
1-29-1, Nanakuni, Hachioji City, Tokyo
Tel
042-632-5900
MEIJI.IRB@meiji.com
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）/Beauty & Health Research Inc. (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 27 | 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
40
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
| 2015 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046569
| Research Plan | |
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| 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 |
