UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041199 |
|---|---|
| Receipt number | R000047041 |
| Scientific Title | Confirmation study about effects on intestinal microbiota and safety of dietary fiber mixture powder intake in healthy subjects |
| Date of disclosure of the study information | 2021/07/26 |
| Last modified on | 2021/08/19 17:03:00 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047041
