UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of a food containing Curcuma longa on liver function
Title of the study (Brief title)	A study to evaluate the effect of a food containing Curcuma longa on liver function
Region	Japan

Condition
Condition	N/A
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study examine effect of a food containing Curcuma longa for improving liver function for 8 weeks ingestion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Aspartate aminotransferase (AST) at 0, 4, 8 weeks in the intervention and 4 weeks after the intervention. 2. Alanine aminotransferase (ALT) at 0, 4, 8 weeks in the intervention and 4 weeks after the intervention. 3. Gammma glutamyltransferase (Gammma-GTP) at 0, 4, 8 weeks in the intervention and 4 weeks after the intervention.
Key secondary outcomes	1.Questionnaire survey (POMS-Brief) at 0, 4, 8 weeks in the intervention and 4 weeks after the intervention.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test product containing low dose of Curcuma longa (5 tablets per a day; 8 weeks)
Interventions/Control_2	Oral ingestion of the test product containing high dose of Curcuma longa (5 tablets per a day; 8 weeks)
Interventions/Control_3	Oral ingestion of the test product not containing Curcuma longa (5 tablets per a day; 8 weeks)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Males and females from 20 to 64 years of age (2) Participants whose AST levels are <40 U/L and ALT levels are <45 U/L based on the results of preliminary examination (3) Participants who have a drinking habit (>=5 days a week) (4) Participants whose BMI are >=18 and <30 based on the results of preliminary examination (5) ALT levels were top 48 out of the participants applying to the criteria (1) - (4)
Key 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) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	48

Research contact person
Name of lead principal investigator	Yoshihiro Yamamoto
Organization	House Wellness Foods Corporation
Division name	Research and Development Institute
Address	Imoji 3-20, Itami, Hyogo
TEL	072-778-1121
Email	Yamamoto_Yoshihiro@house-wf.co.jp

Public contact
Name of contact person	Kawasaki Kengo
Organization	House Wellness Foods Corporation
Division name	Research and Development Institute
Address	Imoji 3-20, Itami, Hyogo
TEL	072-778-1127
Homepage URL
Email	Kawasaki_Kengo@house-wf.co.jp

Sponsor
Institute	House Wellness Foods Corporation Research and Development Institute
Institute
Department

Funding Source
Organization	House Wellness Foods Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 12 Day
Anticipated trial start date	2014 Year 05 Month 12 Day
Last follow-up date	2014 Year 08 Month 14 Day
Date of closure to data entry	2014 Year 08 Month 29 Day
Date trial data considered complete	2014 Year 08 Month 30 Day
Date analysis concluded	2014 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 25 Day
Last modified on	2017 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031496