UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate effects of a food containing Curcuma longa on adults whose liver function is healthy
Title of the study (Brief title)	Effects of Curcuma longa on liver function in healthy adults
Region	Japan

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

Objectives
Narrative objectives1	This study examine effects of 12-weeks ingestion of a food containing Curcuma longa for improving liver function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	At 0, 4, 8, 12 weeks in the intervention and 4 weeks after the intervention. [1]Aspartate aminotransferase (AST) [2]Alanine aminotransferase (ALT)
Key secondary outcomes	At 0, 4, 8, 12 weeks in the intervention and 4 weeks after the intervention. [1]Gammma glutamyltransferase (Gammma-GTP) [2]Questionnaire survey (POMS-Brief) At 0, 12 weeks in the intervention. [3]Tumor Necrosis Factor-alpha (TNF-alpha) [4]Interleukin-6 (IL-6) [5]C-reactive protein (CRP) [6]Prostaglandin E2 (PGE2) [7]Serum amyloid A protein (SAA)

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test product containing Curcuma longa (3 tablets per a day; 12 weeks)
Interventions/Control_2	Oral ingestion of the test product not containing Curcuma longa (3tablets per a day; 12 weeks)
Interventions/Control_3
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females over the age of 19 years (2) Participants whose AST and ALT levels are <51 U/L (3) Participants whose BMI are >=24 and <30
Key exclusion criteria	(1) Participants whose HCV antibody or HbsAg are positive (2) Participants whose systolic blood pressure are lower than 90 mmHg (3) Participants who are possibly pregnant, pregnant, or lactating (4) Participants who have made a blood donation of 200 mL within the last one month prior to this study (5) Male participants who have made a blood donation of 400 mL within the last three months prior to this study (6) Female participants who have made a blood donation of 400 mL within the last four months prior to this study (7) Male participants who have made a blood donation over an amout (1,200 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study (8) Female participants who have made a blood donation over an amout (800 mL minus the estimated volume of blood sampling during the study) within the last one year prior to this study (9) Participants who are participating in another clinical study or had finished another clinical study within the last four weeks (10) Participants who have heart disease, liver disease, or kidney disease (11) Participants who have any history of cardiovascular disease (12) Participants who are diabetes mellitus (13) Participants have medication or food allergy (14) Participants who have excessive alcohol-drinking or smoking habit (15) Participants who have extremely irregular dietary habits (16) Participants who consecutively intake pharmaceutical or healthcare food which is possible to influence the result of this study (17) Participants judged as unsuitable for the study by the investigator
Target sample size	80

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	Kengo Kawasaki
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	2016 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 25 Day
Anticipated trial start date	2016 Year 02 Month 10 Day
Last follow-up date	2016 Year 07 Month 20 Day
Date of closure to data entry	2016 Year 08 Month 09 Day
Date trial data considered complete	2016 Year 08 Month 30 Day
Date analysis concluded	2016 Year 12 Month 05 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Throughout the intervention period, AST and ALT levels did not differ between groups. For participants whose serum liver enzyme levels were in the borderline range, decreases in AST and ALT levels were significantly greater in the combination group than in the placebo group.
Other related information

Management information
Registered date	2016 Year 02 Month 03 Day
Last modified on	2017 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024067