None listed
Conditions
Interventions
Oral ingestion of the test product containing curcumin and water extract of Curcuma longa containing bisacurone (100 mL per a day
12 weeks)
Oral ingestion of the test product not containing curcumin and water extract of Curcuma longa containing bisacurone (100 mL per a day
Sponsors
House Wellness Foods Corporation Research and Development Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Males and females from 20 to 64 years of age (2) Participants whose BMI are >=24 and <30 based on the results of preliminary examination (3) Participants whose ALT and AST levels are <51 U/L based on the results of preliminary examination (4) ALT levels were top 64 out of the participants applying to the criteria (1) - (3)
Exclusion criteria
Exclusion criteria: (1) Participants who consecutively intake pharmaceutical or healthcare food which is possible to influence liver function (2) Participants who consecutively intake pharmaceutical or healthcare food including Curcuma longa (3) Participants who are judged as unsuitable for the study based on the results of lifestyle questionnaire (4) Participants having possibilities for emerging allergy related to the study (5) Participants having a disease requiring regular medication or a history of serious diseases for which medication was required (6) Participants who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (7) Participants who have participated in other clinical studies (8) Participants who intend to become pregnant or lactating (9) Participants who are positive for HCV antibody or HbsAg (10) Participants judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Aspartate aminotransferase (AST) at 0, 4, 8, 12 weeks in the intervention and 4 weeks after the intervention. [2]Alanine aminotransferase (ALT) at 0, 4, 8, 12 weeks in the intervention and 4 weeks after the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Gammma glutamyltransferase (Gammma-GTP) at 0, 4, 8, 12 weeks in the intervention and 4 weeks after the intervention. [2]Questionnaire survey (POMS-Brief) at 0, 4, 8, 12 weeks in the intervention and 4 weeks after the intervention. | — |
Countries
Japan
Contacts
Public ContactKawasaki Kengo
House Wellness Foods Corporation Research and Development Institute
Outcome results
None listed