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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047751
Receipt No. R000054389
Scientific Title A Study on the Effect of Test food on Subjective symptoms in Aging Men -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2022/05/13
Last modified on 2022/05/10

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Basic information
Public title A Study on the Effect of Test food on Subjective symptoms in Aging Men
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym A Study on the Effect of Test food on Subjective symptoms in Aging Men
Scientific Title A Study on the Effect of Test food on Subjective symptoms in Aging Men
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym A Study on the Effect of Test food on Subjective symptoms in Aging Men
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effect of test food on subjective symptoms in aging men
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes questionnaire
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 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Active food A,
8 weeks consumption
Interventions/Control_2 Active food B,
8 weeks consumption
Interventions/Control_3 Placebo food,
8 weeks consumption
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
35 years-old <=
Age-upper limit
65 years-old >
Gender Male
Key inclusion criteria 1) Healthy males aged 35 to 64 years-old.
2) Subjects who are aware of feelings of decreased libido, etc.
3) Subjects whose total testosterone levels in blood are 250 ng/dL or over.
4) Subjects whose BMI are less than 30.
5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria 1) Subjects who contract sexual dysfunction (erectile dysfunction, etc.).
2) Subjects who contract, are under treatment for serious diseases (e.g., diabetes, kidney and liver disease, and heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
3) Subjects who have a chronic disease and regularly use medications.
4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
5) Subjects who are judged as unsuitable for the current study by screening test.
6) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims).
7) Subjects who have excessive alcohol intake more than approximately 20 g / day of pure alcohol equivalent or habit of drinking 4 or more days per week.
8) Subjects who can't stop drinking from a day before each measurement.
9) Subjects who have declared allergic reaction to ingredients of test food.
10) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
11) Subjects who are shiftworker and/or midnight-shift worker.
12) Subjects who plan to travel abroad, including overseas travel, during test periods.
13) Subjects who have donated over 200 mL of blood and/or blood components within the last 4 weeks prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yoshitaka
Middle name
Last name Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code 103-0001
Address Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Komori
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email eigyou27@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization TOYO SHINYAKU 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 Ethical Committee of Kobuna Orthopedics Clinic
Address 5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel 027-212-5608
Email sagawa@mc-connect.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 05 Month 13 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
2022 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2022 Year 05 Month 14 Day
Last follow-up date
2022 Year 08 Month 31 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 05 Month 13 Day
Last modified on
2022 Year 05 Month 10 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054389

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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