UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effects of the intake of cocoa on bowel movement and fecal malodor. A placebo-controlled crossover trial.
Title of the study (Brief title)	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	Masanori Kamei
Organization	Morinaga & CO.,LTD.
Division name	Research Institute
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	Haruka Yoshimoto
Organization	QOL RD Co.,Ltd.
Division name	CRO Department Food Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.lifescience.co.jp/yk/yk17/apr/ab15.html
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.
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