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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027309
Receipt No. R000031291
Scientific Title Study for evaluating the safety of excessive intake of food originated from a microorganism -A randomized, double-blind, placebo-controlled trial.
Date of disclosure of the study information 2017/05/11
Last modified on 2017/10/13

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Basic information
Public title Study for evaluating the safety of excessive intake of food originated from a microorganism -A randomized, double-blind, placebo-controlled trial.
Acronym Study for evaluating the safety of excessive intake of food originated from a microorganism
Scientific Title Study for evaluating the safety of excessive intake of food originated from a microorganism -A randomized, double-blind, placebo-controlled trial.
Scientific Title:Acronym Study for evaluating the safety of excessive intake of food originated from a microorganism
Region
Japan

Condition
Condition None (Healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive intake of food originated from a microorganism.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Interview by physician
2. Height and body weight
3. Blood pressure and pulse
4. Hematological test
5. Blood biochemical analysis
6. Urine analysis
7. Subjective symptom and objective response
8. Adverse events
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Food originated from a microorganism. 5 portion of food per day for 4 weeks.
Interventions/Control_2 Placebo food, 5 portion of food per day 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
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Males and females aged from 20 to less than 65 years old, when giving the informed consent.
(2) Individuals who give the informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will.
Key exclusion criteria (1) Individuals who have a medical history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
(2) Individuals who have chronic diseases and use medicines continuously.
(3) Individuals with excessive alcohol-drinking behaviors (Maximum daily quantity: Approximately 20 g of pure alcohol per day, for example, beer 1 bottle 500 mL, whiskey double 1 cup 60 mL, or wine approximately 1.5 cups 180 mL, respectively) .
(4) Individuals who cannot stop drinking for two days until the screening and each checkup.
(5) Individuals having food allergy.
(6) Individuals who have a medical history of hay fever.
(7) Individuals who have a medical history of diseases affecting digestion and absorption.
(8) Individuals who have tendency to get diarrhea by eating dairy product.
(9) Individuals who have a history of irritable bowel syndrome and Crohns disease.
(10) Individuals who are judged as unsuitable for the study based on the results of blood test.
(11) Individuals who have under treatment or a history of drug addiction and/or alcoholism.
(12) Individuals who are participating or willing to participate in other clinical trials with the intake of food or pharmaceutical products, or with the swab of cosmetic or pharmaceutical products.
(13) Individuals who are pregnant, breastfeeding, or planning to be pregnant in the near future.
(14) Individuals who refuse to answer their biological sex.
(15) Individuals who and whose family work for a company manufacturing or selling healthy foods or functional foods.
(16) Individuals who are judged unsuitable for this study by the investigator for other reasons.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Suzuki
Organization Shinagawa Season Terrace Health Care Clinic
Division name Medical Examination and Treatment Management Family
Zip code
Address The 5th floor of Shinagawa season terrace, 1-2-70 Konan, Minato-ku, Tokyo, Japan
TEL 03-3452-3381
Email satoru_suzuki@sempos.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Corporation
Division name Sales Department
Zip code
Address The 7th floor of Shibaura omodaka building, 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Kirin Company, Limited
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 05 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
2017 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 11 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031291

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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