UMIN-CTR Clinical Trial

Basic information
Public title	Confirmation study about effects on intestinal microbiota and safety of dietary fiber mixture powder intake in healthy subjects
Acronym	Effects of dietary fiber mixture powder on intestinal microbiota
Scientific Title	Confirmation study about effects on intestinal microbiota and safety of dietary fiber mixture powder intake in healthy subjects
Scientific Title:Acronym	Effects of dietary fiber mixture powder on intestinal microbiota
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify effects on intestinal microbiota and safety of the test food intake in healthy males and females with lower tendency of intestinal microbiota diversity.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intestinal microbiota diversity index (Shannon index) after 4 weeks-intake of the test food
Key secondary outcomes	After 4 weeks-intake of the test food: -Intestinal microbiota -Fecal organic acids -Fecal putrefactive products Throughout the intake period: -Stool characteristics -Abdominal symptoms

Base
Study type	Interventional

Study design
Basic design	Parallel
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 test food, two packs a day (one pack at a time, 2 packs in total after breakfast, lunch and/or dinner) for 4 weeks.
Interventions/Control_2	Intake of placebo food, two packs a day (one pack at a time, 2 packs in total after breakfast, lunch and/or dinner) for 4 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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy male and female subjects ranging in age from 20 to 64 on the day of informed consent. (2) Subjects who may be low in intestinal microbiota diversity as follows: -Subjects who are aware of high intake of fats/oils and meats in their daily diet. -Subjects who are aware of low dietary fiber intake in their daily diet. (3) Subjects who give written informed consent to take part in this study after being provided with an explanation of the protocol detail.
Key exclusion criteria	(1) Subjects who take some kind of prescribed medication, including nasal/eye drops or ointments, on the day of informed consent. (2) Subjects who have regularly used and can not stop using the following products that may affect study results from the day of informed consent until the last visit; general drugs, quasi drugs, Food for Specified Health Uses, Foods with Function Claims, health foods, dietary fiber-rich products, etc. (3) Excessive alcohol intake (more than 60 g/day as pure alcohol on average). (4) Vegetarians. (5) Subjects with extremely irregular frequency or timing of meals, and/or midnight work or irregular shift work. (6) Subjects who are under the other clinical study related to medicine/food, have taken part in those studies within four weeks or be planning to participate in after informed consent. (7) Currently pregnant, intended to become pregnant or nursing an infant. (8) Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (9) Subjects with previous medical history of drug and/or food allergy. (10) Subjects with weak stomach and/or diarrhea-prone constitution. (11) Subjects who donated their blood (200 mL) and/or blood components within the last one month to this study. (12) Males who donated their blood (400 mL) within the last three months to this study. (13) Females who donated their blood (400 mL) within the last four months to this study. (14) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (15) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study. (16) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Suguru Middle name Last name Fujiwara
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Email	cpcc-contact@cpcc.co.jp

Public contact
Name of contact person	1st name Masanori Middle name Last name Numa
Organization	CPCC Company Limited
Division name	Sales & Planning Department
Zip code	101-0047
Address	4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	EN Otsuka Pharmaceutical Co., Ltd.
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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2020 Year 07 Month 21 Day
Date of IRB	2020 Year 07 Month 17 Day
Anticipated trial start date	2020 Year 07 Month 27 Day
Last follow-up date	2020 Year 11 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 22 Day
Last modified on	2021 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047041