Healthy adults
Conditions
Interventions
Test food(Intake period:24 weeks)
Control food (Intake period:24 weeks)
Sponsors
APO PLUS STATION CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese male and female aged between 20 to 65 years old at the time of informed consent. 2.Subjects whose BMI is between 25.0 to 30.0 kg/m2. 3.Subjects who agreed to participate in the study on one's own will.
Exclusion criteria
Exclusion criteria: 1.Subjects whose liver stiffness is more than 6.0 kPa. 2.Subjects who had liver disease, or have currently under medical treatment of the liver disease. 3.Subjects who are currently undergoing treatment for serious diseases. 4.Subjects who have average intake of alcohol more than 60 g/day by week. 5.Subjects who have food allergies or who may be allergic to the test food. 6.Subjects who are taking drugs and quasi-drugs that may affect the current study. 7.Subjects who regularly take health foods that may affect the current study. 8.Subjects who will not stop taking the drugs, quasi-drugs and health foods during the study period (after agreeing to the informed consent until the end of the test food ingestion period). 9.Subjects who have extremely irregular lifestyles. 10.Subjects who are currently participating in other studies, or participated in other studies within the past 3 months from the time of the informed consent. 11.Subjects who participate in other studies during this study. 12.Subjects who will not maintain their daily routines. 13.Subjects who have difficulty in taking the test food as instructed. 14.Subjects who are pregnant or breastfeed, or planning to become pregnant during this study 15.Subjects who are consideredas unsuitable participant for the study by the doctor and investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fat content | — |
Secondary
| Measure | Time frame |
|---|---|
| ALT : Alanine Aminotransferase AST : Aspartate Aminotransferase Gamma-GT : Gamma-Glutamic Transpeptidase Low Density Lipoprotein cholesterol High Density Lipoprotein cholesterol Triglyceride Body Weight Body Mass Index Body Fat Percentage | — |
Countries
Japan
Contacts
Public ContactYuki Kitahara
APO PLUS STATION CO., LTD. CRO Department Clinical Operations Division
Outcome results
None listed