UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035740 |
|---|---|
| Receipt number | 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 | 2019/09/17 17:36:46 |
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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
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Takahiro Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
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
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
jimukyoku@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
| 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
60
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
| 2019 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 24 | Day |
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 | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040675
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