UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000036058
Receipt No. R000041072
Scientific Title Effects of consumption of cereal-derived constituent on intestinal environment
Date of disclosure of the study information 2019/03/03
Last modified on 2020/01/09 (Ver. 12)

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Basic information
Public title Effects of consumption of cereal-derived constituent on intestinal environment
Acronym Effects of consumption of cereal-derived constituent on intestinal environment
Scientific Title Effects of consumption of cereal-derived constituent on intestinal environment
Scientific Title:Acronym Effects of consumption of cereal-derived constituent on intestinal environment
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate effects of consumption of cereal-derived constituent (A-001) on related factors to bowl movement and intestinal environment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Bowl movement (amount of stool, defecation frequency) for the 2-wk consumption period.
Key secondary outcomes

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 Treatment
Type of intervention
Food
Interventions/Control_1 2-week consumption of the two test foods with different composition with more than 4-week washout between the interventions.

Ingestion order: food A-001 to food B-001
Interventions/Control_2 2-week consumption of the two test foods with different composition with more than 4-week washout between the interventions.

Ingestion order: food B-001 to food A-001
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
59 years-old >=
Gender Male and Female
Key inclusion criteria 1. defecate two to five times per week
2. provided written informed consent from subjects
Key exclusion criteria 1.Liver, kidney, heart disease, disorder respiration endocrine, metabolism, nervous system consciousness, diabetes, or other diseases
2. Routinely taking laxative product or cathartic
3. Routinely taking health hood which may influence bowel movement
4. Took antibiotic drug within the last month prior to the this study
5. Blood donation of 200 mL or more within l month of this trial
6. Unpleasant feeling during blood drawing
7. Allergy against any constituents in the test diet
8. have a bad stomach after drinking milk
9. pregnant or planning become pregnant
10. judged to be inappropriate as subject by physician in charge
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Shinichiro
Middle name
Last name Saito
Organization Kao Corporation
Division name Biological Science Research
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7456
Email saito.shinichiro@kao.com

Public contact
Name of contact person
1st name Chizuka
Middle name
Last name Suzuki
Organization Kao Corporation
Division name Biological Science Research
Zip code 131-8501
Address 2-1-3 Bunka Sumida-ku Tokyo
TEL 03-5630-7456
Homepage URL
Email suzuki.chizuka@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kao Corporation Human Research IRB
Address 2-1-3 Bunka Sumida-ku Tokyo
Tel +81-3-5630-7263
Email morisaki.naoko@kao.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 花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 03 Day

Related information
URL releasing protocol Unpublished due to the protocol including the intellectual property rights
Publication of results Published

Result
URL related to results and publications works in progress
Number of participants that the trial has enrolled 17
Results 
Significant effect in the primary outcome
Results date posted
2020 Year 01 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Healthy subjects
Participant flow 
17 participants completed and 10 subjects were incorporated into the analyses
Adverse events 
No significantly difference was observed between A-001 and B-001.
Outcome measures 
Bowl movement (amount of stool, defecation frequency)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2019 Year 01 Month 24 Day
Date of IRB
2018 Year 01 Month 23 Day
Anticipated trial start date
2019 Year 03 Month 04 Day
Last follow-up date
2019 Year 06 Month 24 Day
Date of closure to data entry
2019 Year 12 Month 02 Day
Date trial data considered complete
2019 Year 12 Month 03 Day
Date analysis concluded
2019 Year 12 Month 25 Day

Other
Other related information

Management information
Registered date
2019 Year 03 Month 01 Day
Last modified on
2020 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041072