None listed
Conditions
Interventions
12 weeks).
Sponsors
CXwellness, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Males and postmenopausal females 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] Selected mainly for those with elevated values of liver function-related indicators. [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 regularly use vitamins. [3] Individuals who used or applied a drug for treatment of disease in the past 1 month. [4] Individuals who have, are undergoing treatment, or have a history of serious diseases such as diabetes, kidney disease, liver disease, heart disease, thyroid disease, adrenal disease, and other metabolic diseases. [5] Individuals who contract or have a history of serious endocrine disease. [6] Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [7] Individuals who experienced unpleasant feeling during blood drawing. [8] Individuals who are sensitive to test product or other foods, and medical products (especially allergies to wheat). [9] Individuals with serious anemia. [10] Individuals with bleeding teeth or oral problems, such as periodontal disease or mouth ulcer. [11] Individuals who have significant changes in their physical condition due to menopause. [12] Individuals who regularly use food for specified health use, functional foods, and health foods. [13] Individuals who regularly use foods or supplements containing lactic asid bacteria and bifidobacterium. [14] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [15] Individuals who are smoker. [16] Individuals with possible changes of life style during the test period. [17] Individuals who habitually perform strenuous exercise such as running, marathon, soccer, etc. [18] Individuals who participated in other clinical studies in the past a month. [19] Individuals who are judged inappropriate for the study by the principal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT(Week 0, Week 8 and Week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary outcomes [1] AST (1) [2] Gamma -GT (1) [3] Specific blood test (1) [4] 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] Subject's diary (2) [7] Doctor's questions (1) [8] Adverse events: number of cases and expression rate of adverse events (3) (1): Week 0, Week 8 and Week 12 (2): From the first day of intake of test food to the last day of the test. (3): Week 8, Week 12 | — |
Countries
Japan
Contacts
Public ContactTatsuo Uetake
CXwellness, Inc. Representative Director
Outcome results
None listed