UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Acronym	Effects of consumption of the test food on bowel movement and intestinal environment
Scientific Title	Effects of consumption of the test food on bowel movement and intestinal environment: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	Effects of consumption of the test food on bowel movement and intestinal environment
Region	Japan

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

Objectives
Narrative objectives1	To verify the effects of the test food on bowel movement and intestinal environment on the healthy Japanese adult subjects who defecate three to five times per week and do not eat enough fiber
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Defecation frequency *1 Record the bowel movement diary from a week before screening (before consumption) to the day before screening (before consumption) and from a week before consuming to the day before 4 weeks after consuming (total 3 weeks)
Key secondary outcomes	1. Defecation days 2. Amount of defecation 3. Shape of stool 4. Smell of stool 5. Exhilarating feeling 6. Bifidobacterium 7. Lactobacillales 8. Bacteroides 9. Prevotella 10. Clostridium cluster IV 11. Clostridium cluster IX 12. Clostridium cluster XI 13. Clostridium subcluster XIVa 14. Clostridium cluster XVIII 15. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) 16. Bristol stool scale 17. Succinic acid 18. Lactic acid 19. Formic acid 20. Acetic acid 21. Propionic acid 22. iso-Butyric acid 23. n-Butyric acid 24. iso-Valeric acid 25. n-Valeric acid *1-5 Record the bowel movement diary from a week before screening (before consumption) to the day before screening (before consumption) and from a week before consuming to the day before 4 weeks after consuming (total 3 weeks) *6-25 Assess the measured values or the amount of change at screening (before consumption) and at 2 weeks after consumption

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 2 weeks Test food: Tablets containing mulukhiya Administration: Take a total of 30 tablets per day between meals with water and no chewing
Interventions/Control_2	Duration: 2 weeks Test food: Placebo tablets Administration: Take a total of 30 tablets per day between meals with water and no chewing
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy subjects 2. Japanese adult subjects 3. Subjects who defecate three to five times per week 4. Subjects who do not eat enough fiber in usual dietary life 5. Subjects who are determined as eligible to participate in the study by the physician 6. Subjects who have relatively a few defecation frequencies at a week before screening (before consumption)
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines) and dietary supplements 6. Subjects who regularly use anticoagulants, such as warfarin 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, breast-feeding, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are ineligibility to participate in the study based on the evaluation of the physician
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	AOTSUBU CO.,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 21 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	https://ffhdj.com/index.php/ffhd/article/view/686
Number of participants that the trial has enrolled	22
Results	Nagahara H, Nagahara M, Ohmi N, Takahashi Y, Takara T. Bowel movement improvement by Mulukhiyah (Corchorus olitorius)-containing food (AOTSUBU) consumption: A randomized, double-blind, placebo-controlled, parallel-group comparison trial. FFHD 2020; 10(5): 210-227
Results date posted	2021 Year 05 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 03 Month 18 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 01 Month 07 Day
Date of IRB	2019 Year 01 Month 07 Day
Anticipated trial start date	2019 Year 01 Month 22 Day
Last follow-up date	2019 Year 04 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 21 Day
Last modified on	2021 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040573