UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049636 |
|---|---|
| Receipt number | R000056524 |
| Scientific Title | Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2022/11/28 |
| Last modified on | 2023/08/24 14:29:32 |
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Basic information
Public title
Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects
Acronym
Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects
Scientific Title
Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on the intestinal environment in healthy Japanese subjects
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 consumption of the test food on the intestinal environment in healthy Japanese subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The numbers of Bifidobacterium genus at three weeks after consumption
Key secondary outcomes
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
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: Three weeks
Test food: Food containing galactooligosaccharide
Administration: Take one packet with approximately 120 ml of water without vapour (room temperature or chilled) at any time during the day once daily. At that time, completely dissolve the powder in the packet in water with the provided dropper and take it at once.
*Because the test food is in powder form and is likely to remain inside the aluminum pouch packet due to its high hygroscopicity, use a dropper to dissolve the test food in water and take it, and check the inside of the packet as carefully as possible to avoid remaining inside the packet
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Interventions/Control_2
Duration: Three weeks
Test food: Food not containing galactooligosaccharide
Administration: Take one packet with approximately 120 ml of water without vapour (room temperature or chilled) at any time during the day once daily. At that time, completely dissolve the powder in the packet in water with the provided dropper and take it at once.
*Because the test food is in powder form and is likely to remain inside the aluminum pouch packet due to its high hygroscopicity, use a dropper to dissolve the test food in water and take it, and check the inside of the packet as carefully as possible to avoid remaining inside the packet
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Subjects whose numbers of Bifidobacterium genus is not zero (whose Bifidobacterium genus can be detected) at screening (before consumption; Scr)
6. Subjects whose numbers of Bifidobacterium genus is few at Scr
Key exclusion criteria
Subjects (who/whose)
1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. have a pacemaker or an implantable cardioverter defibrillator
3. currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. are currently taking medications (including herbal medicines) and supplements
6. are allergic to medicines and/or the test food related products (particularly, galactooligosaccharide)
7. are pregnant, lactating, or planning to become pregnant during this trial
8. suffer from COVID-19
9. have been enrolled in other clinical trials within the last 28 days before agreeing to participate or plan to participate another trial during this trial
10. are judged as ineligible in this study by the physician
11. have lactose intolerance
12. have a medical history of autoimmune disease or sea squirt asthma
13. usually take food/beverage containing functional ingredients that may influence the intestinal environment (e.g. dietary fiber, indigestible dextrin, isomaltodextrin, inulin, guar gum degradation products, fructooligosaccharides, galactooligosaccharides, lactulose, lactic acid bacteria, bifidobacteria, butyric acid bacteria, Bacillus subtilis var. natto, maltobionic acid, fucose, cocoa polyphenols, raffinose, kestose, polydextrose, lactosucrose, xylooligosaccharide, isomaltooligosaccharide, psyllium, resistant starch, galactomannan, or glucomannan)
14. usually take fermented foods (e.g. yogurt or natto), foods with rich dietary fiber (e.g. brown rice or green juice), or foods containing oligosaccharide (e.g. banana or honey)/who take them to improve the intestinal environment
15. food intake was extremely high/low right before Scr
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
Nissin Sugar Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi 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
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 28 | 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
56
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
| 2022 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056524
