UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation test on intestinal environment improvement effect by ingesting chocolate
Title of the study (Brief title)	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	Maiko Tajima
Organization	Beauty & Health Research_Inc
Division name	Medical Research Department
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	Ai Marume
Organization	Beauty & Health Research_Inc
Division name	Medical Research Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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