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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022433
Receipt No. R000025852
Scientific Title A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor. A placebo-controlled crossover trial.
Date of disclosure of the study information 2017/09/30
Last modified on 2017/07/21

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Basic information
Public title A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor. A placebo-controlled crossover trial.
Acronym A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor.
Scientific Title A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor. A placebo-controlled crossover trial.
Scientific Title:Acronym A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor.
Region
Japan

Condition
Condition Subjects with a tendency for constipation
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effects of cocoa on the improvement of bowel movement and fecal malodor of subjects with a tendency for constipation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation frequency, fecal amount, fecal odor
Key secondary outcomes Fecal conditions(fecal hardness, fecal color, fecal shape, feeling after defecation), fecal ammonia content, fecal putrefaction products content(indole, skatol)

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 Intake of a drink containing cocoa for 2 weeks, wash out for 2 weeks, Intake of a drink without cocoa for 2 weeks
Interventions/Control_2 Intake of a drink without cocoa for 2 weeks, wash out for 2 weeks, Intake of a drink containing cocoa for 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
60 years-old >=
Gender Male and Female
Key inclusion criteria (1)Males and females from 20 to 60 years old
(2)Subjects with a tendency for constipation at two to five times defecation per week
(3)Healthy subjects with not taking any medicine
(4)Subjects who can keep their stools in freeze immediately after defecation
(5)Obtaining informed consent and signed a consent form
Key exclusion criteria 1) Subjects with a serious liver, kidney, heart damage, diabetes, food allergies, digestive disorder, suffering other serious diseases
2) Subjects having medical history or operation history of digestive disorder
3) Subjects cannot keep the lifestyle
4) Subjects cannot regularly have three meals a day
5)Shifts workers or Late-night workers
6) Subjects whose amount of dietary intake or exercise has changed significantly
7) Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study.
8) Subjects who take any kind of medicine and/or food for specified health uses and/or supplements and/or diet foods
9) Subjects with drug and food allergies
10) Subjects with a hypersensitivity reaction to test food (eczema, nausea, diarrhea, etc.)
11) Subjects cannot ingest the test food as directed
12) Subjects who usually drink more than 500ml of beer in terms of per day
13) Subjects who take dietary fiber, fermented foods, foods containing a lot of lactic acid bacteria or bifidobacteria or another living bacteria or oligosaccharide or chocolate or cocoa
14) Subjects who will smoke during the test period
15) Subjects cannot wright a life diary everyday
16) Subjects who cannot avoid food intake, which influences on fecal odor, on the day before sampling feces
17) Subjects who participate other clinical trials or investigates in this trial
18) Subjects who are judged not applicable to this study by representative investigator or investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Kamei
Organization Morinaga & CO.,LTD.
Division name Research Institute
Zip code
Address 2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL 045-571-6140
Email m-kamei-hd@morinaga.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruka Yoshimoto
Organization QOL RD Co.,Ltd.
Division name CRO Department Food Division
Zip code
Address 2-14-1, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL 03-6386-8809
Homepage URL
Email h-yoshimoto@qol-rd.co.jp

Sponsor
Institute QOL RD Co.,Ltd.
Institute
Department

Funding Source
Organization Morinaga & CO.,LTD.
Organization
Division
Category of Funding Organization Self funding
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 関野臨床薬理クリニック(東京都)、白岡中央総合病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.lifescience.co.jp/yk/yk17/apr/ab15.html
Number of participants that the trial has enrolled
Results
Consumption of 10 g cocoa once a day for 2 weeks improved defecation frequency and fecal odor in the test subjects. The principal ingredient contributing to both improvements is thought to be lignin, an insoluble dietary fiber contained in cocoa.
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 05 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 25 Day
Last follow-up date
Date of closure to data entry
2016 Year 12 Month 20 Day
Date trial data considered complete
2017 Year 02 Month 28 Day
Date analysis concluded
2017 Year 03 Month 25 Day

Other
Other related information Evidence of Bowel Movement and Fecal Odor Improvement by Cocoa-derived Lignin Consumption
-A Randomized, Double-blind, Cross-over Study-

K. Sugiyama et al.

MORINAGA & CO.,LTD.

Management information
Registered date
2016 Year 05 Month 24 Day
Last modified on
2017 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025852

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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