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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020858
Receipt No. R000024067
Scientific Title A study to evaluate effects of a food containing Curcuma longa on adults whose liver function is healthy
Date of disclosure of the study information 2016/02/03
Last modified on 2017/08/09

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Basic information
Public title A study to evaluate effects of a food containing Curcuma longa on adults whose liver function is healthy
Acronym Effects of Curcuma longa on liver function in healthy adults
Scientific Title A study to evaluate effects of a food containing Curcuma longa on adults whose liver function is healthy
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshihiro Yamamoto
Organization House Wellness Foods Corporation
Division name Research and Development Institute
Zip code
Address Imoji 3-20, Itami, Hyogo
TEL 072-778-1121
Email Yamamoto_Yoshihiro@house-wf.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Kawasaki
Organization House Wellness Foods Corporation
Division name Research and Development Institute
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 01 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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