None listed
Conditions
Interventions
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] Males aged 40-65 years, at the time of obtaining consent to participate in this study. [2] Individuals who are healthy and have no chronic physical disease. [3] Individuals with higher liver function-related indexes. [4] Individuals whose BMI is more than 23.0 kg/m2 and less than 30.0 Kg/m2. [5] Individuals whose written informed consent has been obtained after explanation of this study. [6] Individuals who can have an examination on a designated check day. [7] Individuals who are judged appropriate for the study by the principal.
Exclusion criteria
Exclusion criteria: [1] Individuals who are currently receiving drug treatment due to some kind of illness. In addition, individuals who regularly use drugs or quasi-drugs for purposes other than disease treatment. [2] Individuals who used or applied a drug for treatment of disease in the past 1 month. [3] Individuals who have, are undergoing treatment for, or have a history of serious diseases such as diabetes, kidney disease, liver disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases. [4] Individuals who contract or have a history of serious endocrine disease. [5] Individuals with serious anemia. [6] Individuals with bleeding teeth or oral problems, such as periodontal disease or mouth ulcer. [7] Individuals who may have allergic symptoms to test product or wheat, other foods, and medical products. [8] Individuals who regularly use food for specified health use, functional foods, and health foods. [9] Individuals who regularly use foods and supplements containing vitamins, lactic acid bacteria and bifidobacteria [10] Individuals who regularly drink alcohol (excessive alcohol drinkers). [11] Individuals who are smoker. (including electronic cigarettes) [12] Individuals with possible changes of lifestyle during the test period. [13] Individuals who have habits to do high-intensity exercises such as running, marathon, or soccer. [14] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [15] Individuals who participated in other clinical studies in the past 1 month. [16] Individuals who are judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT(Week 0, Week 6 and Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1] AST (1) [2] Gamma -GT (1) [3] Brief-type self-administered diet history questionnaire (1) *Safety [1] Blood pressure, pulsation (1) [2] Weight, body fat percentage, BMI (1) [3] Hematologic test (1) [4] Blood biochemical test (1) [5] Urine analysis (1) [6] Doctor's questions (1) [7] Adverse events: number of cases and expression rate of adverse events (2) [8] Subject's diary (3) (1): Week 0, Week 6 and Week 12 (2): Week 6, Week 12 (3): From the first day of ingestion of a test material to the last day of the test. | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed