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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020165
Receipt No. R000023298
Scientific Title Validation study for intentional flora effects with "health beverage" in healthy Japanese adults: a double-blind randomized controlled trial
Date of disclosure of the study information 2015/12/11
Last modified on 2017/01/30

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Basic information
Public title Validation study for intentional flora effects with "health beverage" in healthy Japanese adults: a double-blind randomized controlled trial
Acronym Validation study for intentional flora effects with "health beverage" in healthy Japanese adults
Scientific Title Validation study for intentional flora effects with "health beverage" in healthy Japanese adults: a double-blind randomized controlled trial
Scientific Title:Acronym Validation study for intentional flora effects with "health beverage" in healthy Japanese adults
Region
Japan

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

Objectives
Narrative objectives1 We investigate the effect of "health beverage" to intentional flora in healthy Japanese adults.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Intestinal bacterial flora (0 weeks & 12 weeks)
Key secondary outcomes Measure pH of stool (0 weeks & 12 weeks)
High sensitivity CRP (0 weeks & 12 weeks)
The Japanese Version of the Constipation Assessment Scale MT version (0 weeks & 12 weeks)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Period: 12 weeks
Test food: "health beverage"
Dose: Drink 1 bottle of "health beverage", three times a day
Usage: Drink 1 bottle of "health beverage" with the meal (morning, lunch, and dinner)
Interventions/Control_2 Period: 12 weeks
Test food: water (placebo)
Dose: Drink 1 bottle of water, once a day
Usage: intake at optional timing
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 Japanese adults
2. The person who defecate three to five times per week
Key exclusion criteria 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Currently taking medicines (including Chinese medicines), herbal medicines

4. Usually taking Food for Specified Health Uses (FOSHU), Functional display food, yogurt or lactic acid bacteria beverage, which are related with intestinal regulation.

5. Allergic to medicines or foods related to the test food of this trial

6. Usually taking supplements or nutrient function foods in daily

7. Pregnant, lactating, or planning to get pregnant during the trial period

8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial

9. Judged unsuitable for participating in this trial by physician
Target sample size 20

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

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

Sponsor
Institute ORTHOMEDICO, Inc.
Institute
Department

Funding Source
Organization Atom Japan, INC.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Seishin-kai Medical Association Inc, Takara Medical Clinic.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 11 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
2015 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 14 Day
Last follow-up date
2016 Year 07 Month 20 Day
Date of closure to data entry
2016 Year 07 Month 20 Day
Date trial data considered complete
2016 Year 07 Month 20 Day
Date analysis concluded
2016 Year 07 Month 20 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 11 Day
Last modified on
2017 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023298

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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