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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035740
Receipt No. R000040675
Scientific Title A Study for the Effect of the Test Food for Improvement of Postmenopausal Female's QOL and Its Safety.
Date of disclosure of the study information 2019/02/01
Last modified on 2019/02/01

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Basic information
Public title A Study for the Effect of the Test Food for Improvement of Postmenopausal Female's QOL and Its Safety.
Acronym A Study for the Effect of the Test Food for Improvement of Postmenopausal Female's QOL and Its Safety.
Scientific Title A Study for the Effect of the Test Food for Improvement of Postmenopausal Female's QOL and Its Safety.
Scientific Title:Acronym A Study for the Effect of the Test Food for Improvement of Postmenopausal Female's QOL and Its Safety.
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to evaluate efficacy of the test food for improvement of postmenopausal female's QOL and its safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Simplified Menopausal Index (Screening, Week 0, Week 4, Week 8, Week 12).
Key secondary outcomes *Secondary outcomes
[1]Anti-Aging QOL Common Questionnaire (Screening, Week 0, Week 4, Week 8, Week 12).
[2]SF-36v2 Japanese version (Week 0, Week 4, Week 8, Week 12).
[3]OSA sleep inventory (Week 0, Week 4, Week 8, Week 12).
[4]Evaluation of the brain function with Cognitrax (Screening, Week 0, Week 12).

*Safety
[1]Blood pressure (Screening, Week 0, Week 8, Week 12).
[2]Weight, body fat percentage, BMI (Screening, Week 0, Week 8, Week 12).
[3]Blood test (Week 0, Week 12).
[4]Blood biochemical test (Week 0, Week 12).
[5]Endocrine examination (Week 0, Week 12).
[6]Urine analysis (Week 0, Week 12).
[7]Doctor's questions (Screening, Week 0, Week 8, Week 12).
[8]Subject's diary (From the first day of ingestion of a test material to the last day of the test).

*Other index
[1]Evaluation of equol-producing ability (Screening).

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 ingestion of the test products (2 pills/day; 12 weeks).
Interventions/Control_2 Oral ingestion of the placebo products (2 pills/day; 12 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
40 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria [1]Males aged 40-65 years of postmenopausal females.
[2]Individuals who are healthy and don't receive treatment.
[3]Individuals who have menopausal symptom(s).
[4]Individuals who fell fatigued, are bad falling asleep, or sleep badly.
[5]Individuals whose written informed consent has been obtained.
[6]Individuals who can come to the designated venue for this study and be inspected.
[7]Individuals judged appropriate for the trial 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. Individuals who use a drug for treatment of disease.
[3]Individuals who use a drug to treat a disease in the past 1 month.
[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 who conduct hormone replacement therapy.
[7]Individuals whose BMI is over 30.
[8]Individuals with serious anemia.
[9]Individuals who are sensitive to a test product or other foods, and medical products.
[10]Individuals who are alcoholism or excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[13]Individuals who will ingest health-promoting foods, foods for specified health uses, health foods, or supplements.
[14]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company.
[17]Individuals judged inappropriate for the trial by the principal.
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takahiro Ono
Organization Ueno-Asagao Clinic
Division name Head
Zip code
Address 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL +81-3-6240-1162
Email info@ueno-asagao.clinc

Public contact
1st name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Division name Administrative Department of Clinical Trials
Zip code
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 Daicel Corporation
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
2019 Year 02 Month 01 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
2019 Year 01 Month 16 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 26 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
2019 Year 02 Month 01 Day
Last modified on
2019 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040675

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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