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UMIN-CTR Clinical Trial |
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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 |
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- |
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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- |
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Scientific Title:Acronym | A Study on the Effect of Test food on Subjective symptoms in Aging Men | |
Region |
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Condition | ||
Condition | No | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Active food A,
8 weeks consumption |
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Interventions/Control_2 | Active food B,
8 weeks consumption |
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Interventions/Control_3 | Placebo food,
8 weeks consumption |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
yiwama@well-sleep.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |