UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048948 |
|---|---|
| Receipt number | R000055478 |
| Scientific Title | Effect of the Test Food on Male's Vitality and Energy. |
| Date of disclosure of the study information | 2022/09/17 |
| Last modified on | 2023/08/03 11:40:16 |
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Basic information
Public title
Effect of the Test Food on Male's Vitality and Energy.
Acronym
Effect of the Test Food on Male's Vitality and Energy.
Scientific Title
Effect of the Test Food on Male's Vitality and Energy.
Scientific Title:Acronym
Effect of the Test Food on Male's Vitality and Energy.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of the test food on male's vitality and energy and its safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indexes to evaluate vitality and energy (Aging Male Symptoms ; Week 0, home survey, Week 8).
Key secondary outcomes
*Secondary indexes
[1] Visual Analogue Scale (Week 0, home survey, Week 8).
[2] Total testosterone (Week 0, Week 8).
*Safety indexes
[1] Blood pressure, pulsation (Week 0, Week 8).
[2] Weight, body fat percentage, BMI (Week 0, Week 8).
[3] Doctor's questions (Week 0, Week 8).
[4] Subject's diary (From the first day of ingestion of a test material to the last day of the test).
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
Oral ingestion of the test products (6 pills/day; 8 weeks).
Interventions/Control_2
Oral ingestion of the placebo products (6 pills/day; 8 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
Male
Key inclusion criteria
[1] Japanese males aged 40-64 years.
[2] Individuals who are healthy and are not received treatment of disease.
[3] Individuals who have physical, mental, and sexual general malaise of male menopause.
[4] Individuals whose written informed consent has been obtained.
[5] Individuals who can come to the designated venue for this study and be inspected.
[6] Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1] Individuals whose AMS' total score is over 50.
[2] Individuals whose AMS' mental subscale score is over 12.
[3] Subjects who score 11 or more on QIDS-J
[4] Individuals using medical products.
[5] Individuals who have a history of diabetes, erectile dysfunction, benign prostatic hyperplasia, gastric ulcer, mental disease, taste disorder or anemia.
[6] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[7] Individuals who are a patient or have a history of or endocrine disease.
[8] Individuals who use a drug to treat a disease in the past 1 month.
[9] Individuals whose BMI is over 30.
[10] Individuals who are sensitive to foods, and medical products.
[11] Individuals who will ingest health-promoting foods, foods for specified health uses, health foods, or supplements.
[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 had a habit to ingest health functional foods (ex. Food for Specified Health Uses), health foods or supplements with effects on sleep or physical fatigue in the past 1 month or will ingest those foods during the test period.
[14] Individuals who are alcoholism or excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[15] Individuals who are a smoker.
[16] Individuals whose life style will change during the test period (ex. travel for a long time).
[17] Individuals who participated in other clinical studies in the past three months.
[18] Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company.
[19] Individuals judged inappropriate for the trial by the principal.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakajima |
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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical 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
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
| 2022 | Year | 09 | Month | 17 | 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
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055478
