UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022433 |
|---|---|
| Receipt number | 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 12:42:16 |
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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
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
h-yoshimoto@qol-rd.co.jp
Sponsor or person
Institute
QOL RD Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025852
