UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031487
Receipt No. R000035945
Scientific Title Test of the effect of zinc intake on changes of zinc concentration in the semen
Date of disclosure of the study information 2018/02/26
Last modified on 2018/03/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Test of the effect of zinc intake on changes of zinc concentration in the semen
Acronym Test of the effect of zinc intake on changes of zinc concentration in the semen
Scientific Title Test of the effect of zinc intake on changes of zinc concentration in the semen
Scientific Title:Acronym Test of the effect of zinc intake on changes of zinc concentration in the semen
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the amount of change by zinc intake in zinc concentration quantitatively measured in the semen.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal bacterial flora at the beginning of the test, after ingestion of two weeks, and after ingestion of four weeks
Key secondary outcomes Semen test (ejaculate size, sperm concentration, total sperm number, leukocyte number, malformation rate of sperm, testosterone, creatine, polyamine, 8-OHdG, BDNF, oxytocin, total protein amount, fatty acid, organic acid, amino acid, carbohydrate, cholesterol, HPV etc.) at the beginning of the test, after ingestion of two weeks, and after ingestion of four weeks and questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingest total 30 mg of zinc per day
Interventions/Control_2 None
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1. Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2. Healthy Japanese men who are 20 years old or more
Key exclusion criteria 1. Persons who have a chronic disease and is under medication, or has a serious disease history
2. Persons who are allergic to the test food
3. Persons who are judged inappropriate for the exam by the principal investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Takimoto
Organization Dantte Co., Ltd.
Division name Representative director
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Email takimoto@dantte.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke Takimoto
Organization Dantte Co., Ltd.
Division name Representative director
Zip code
Address Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL 03-6809-2722
Homepage URL
Email takimoto@dantte.jp

Sponsor
Institute Dantte Co., Ltd.
Institute
Department

Funding Source
Organization Dantte Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 02 Month 26 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
2018 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2018 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
2018 Year 02 Month 26 Day
Last modified on
2018 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035945

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.