Unique ID issued by UMIN | UMIN000019007 |
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Receipt number | R000021986 |
Scientific Title | A study to evaluate the effect of a food containing Curcuma longa on liver function |
Date of disclosure of the study information | 2015/09/14 |
Last modified on | 2016/11/24 15:50:37 |
A study to evaluate the effect of a food containing Curcuma longa on liver function
A study to evaluate the effect of a food containing Curcuma longa on liver function
A study to evaluate the effect of a food containing Curcuma longa on liver function
A study to evaluate the effect of a food containing Curcuma longa on liver function
Japan |
N/A
Adult |
Others
NO
This study examine effect of a food containing Curcuma longa for improving liver function for 12 weeks ingestion.
Efficacy
[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.
[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.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
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; 12 weeks)
20 | years-old | <= |
65 | years-old | > |
Male and Female
(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)
(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
60
1st name | |
Middle name | |
Last name | Yoshihiro Yamamoto |
House Wellness Foods Corporation
Research and Development Institute
Imoji 3-20, Itami, Hyogo
072-778-1121
Yamamoto_Yoshihiro@house-wf.co.jp
1st name | |
Middle name | |
Last name | Kawasaki Kengo |
House Wellness Foods Corporation
Research and Development Institute
Imoji 3-20, Itami, Hyogo
072-778-1127
Kawasaki_Kengo@house-wf.co.jp
House Wellness Foods Corporation Research and Development Institute
House Wellness Foods Corporation
Profit organization
NO
2015 | Year | 09 | Month | 14 | Day |
Published
Throughout the intervention period, AST and ALT levels did not differ between groups. After excluding participants whose BMI changed substantially during the study period, decreases in AST levels were significantly greater and those in ALT levels tended to be greater in the test group than in the placebo group for participants whose serum liver enzyme levels were in the normal range.
Completed
2015 | Year | 01 | Month | 09 | Day |
2015 | Year | 02 | Month | 21 | Day |
2015 | Year | 07 | Month | 21 | Day |
2015 | Year | 07 | Month | 29 | Day |
2015 | Year | 07 | Month | 30 | Day |
2015 | Year | 10 | Month | 09 | Day |
2015 | Year | 09 | Month | 14 | Day |
2016 | Year | 11 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021986
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