Healthy person
Conditions
Interventions
investigational material(s)
Generic name etc : NKSP(food)
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : once/day,3
Sponsors
Rohto pharmaceutical CO.,LTD
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) 35 to 44 years old(Smoker and non-smoker) (2) Non-somker subjects who need to have stopped smoking 3 months prior to the trial or (3) Smoker subjects who have to be smoking one box of paper cigarettes for an average day (4) BMI range: 18.5-25.0 kg/m2 (5) Drinking less than 20g of pure alcohol (2 unit equivalence) per average day (6) Subjects who can attend designated fixed period measurement schedule and take test items (7) Subjects who aren't using medications or supplememts which may influence the study 3 months prior to the trial (8) Subjects who understand the main points of the study and signs a consent form (9) Subjects who can provide semen for the evaluation
Exclusion criteria
Exclusion criteria: (1) Subjects having a fertility treatment (2) Subjects having treatment with Urologist or Obsterician (3) Subjects with infection and severe injury (4) Subjects who have had an operation within 6 months of starting the trial (5) Subjects who have allergies with the test items (6) Subjects with liver, renal and other dysfunction or medical history which may influence the reserch (7) Subjects who participate in other clinical and or laboratory tests 3 months prior of the the test or duration the trial (8) Subjects judged to be unsuitable as a subject as a result of the questionnaire (9) Subjects who are judged as inappropriate by the study personnel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| other 8-OHdG | — |
Secondary
| Measure | Time frame |
|---|---|
| other Testosterone, creatine, spermine, zinc, sperm concentration, semen volume and total sperm number | — |
Countries
Japan
Outcome results
None listed