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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042409
Receipt No. R000048401
Scientific Title Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Date of disclosure of the study information 2020/11/11
Last modified on 2020/11/10

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Basic information
Public title Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Acronym Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Scientific Title Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Scientific Title:Acronym Safety of Overconsumption of a Functional Food on Healthy Adult Males and Females.
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate safety of overconsumption of a functional food on healthy adult males and females.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4).
Key secondary outcomes *Secondary outcomes
[1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (Week 0, Week 2, Week 4).
[2]Blood pressure, pulsation (Week 0, Week 2, Week 4).
[3]Weight, body fat percentage, BMI (Week 0, Week 2, Week 4).
[4]Hematologic test (Week 0, Week 2, Week 4).
[5]Blood biochemical test (Week 0, Week 2, Week 4).
[6]Urine analysis (Week 0, Week 2, Week 4).
[7]Doctor's questions (Week 0, Week 2, Week 4).

*Other index
[1]Subject's diary (each day during the test period).

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 Treatment
Type of intervention
Food
Interventions/Control_1 Oral intake of the test product (10 capsules in a day; 4 weeks).
Interventions/Control_2 Oral intake of the placebo product (10 capsules in a day; 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 20-64 years.
[2]Individuals who are healthy and have no chronic physical disease including skin disorder.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can come to the designated venue for this study and be inspected.
[5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria [1]Individuals using medical products.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[5]Individuals who are a patient or have a history of or endocrine disease.
[6]Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2.
[7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals who experienced unpleasant feeling during blood drawing.
[10]Individuals who are sensitive to the test food.
[11]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent).
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[13]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[14]Individuals who are or are possibly, or are lactating.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals who are or whose family is engaged in functional foods or cosmetics.
[17]Individuals judged inappropriate for the study by the principal.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kondo
Organization Medical Corporation Meiseikai, Higashi Shinjuku Clinic
Division name Head
Zip code 169-0072
Address 3F Daito Bldg. 1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN
TEL +81-3-6233-8583
Email h.kondo@meiseikai-cl.com

Public contact
Name of contact person
1st name Ryoma
Middle name
Last name Shimizu
Organization TES Holdings Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code 110-0015
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization Nikken Foods 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 Ueno-Asagao Clinic Ethical Review Committee
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel +81-3-6240-1162
Email i.takahashi@tes-h.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
2020 Year 11 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 23 Day
Date of IRB
2020 Year 10 Month 26 Day
Anticipated trial start date
2020 Year 11 Month 12 Day
Last follow-up date
2020 Year 12 Month 14 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 11 Month 10 Day
Last modified on
2020 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048401

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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