None
Conditions
Interventions
Intake of the capsules containing low-dose maltitol for 12 weeks
Intake of the capsules containing high-dose maltitol for 12 weeks
Intake of the placebo capsules for 12 weeks
Sponsors
Soiken Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy subjects aged from 20 to 65 years old 2) Subjects whose serum AST or ALT is 31 IU/L or more and 50 IU/L or less 3) Subjects whose BMI is 18.5 kg/m2 or more and less than 30 kg/m2 4) Subjects who have a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects receiving treatment for fatty liver 2) Subjects receiving treatment for diabetes or dyslipidemia 3) Subjects with suspicion of cirrhosis of the liver 4) Subjects with suspicion of viral hepatitis 5) Subjects with a heavy alcohol consumption (>=30 g/day for men, >=20 g/day for women) 6) Subjects who have severe liver, cardiovascular, respiratory, endocrine or metabolic diseases 7) Subjects who have the possibility of developing allergic symptoms by the test food 8) Subjects who are during pregnancy or lactation, and intend to be pregnant during the study period. 9) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months (e.g. donated blood) prior to the start of the present study 10)Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 11) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AST and ALT (0w, 4w, 8w, 12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatty liver grade determined by abdominal ultrasonography (12w) Body fat percentage (0w, 4w, 8w, 12w) | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. Representative Director
Outcome results
None listed