UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031487
Receipt number 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 18:06:33

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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 or person

Institute

Dantte Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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