UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027489
Receipt number R000031496
Scientific Title A study to evaluate the effect of a food containing Curcuma longa on liver function
Date of disclosure of the study information 2017/05/25
Last modified on 2017/05/25 15:19:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A study to evaluate the effect of a food containing Curcuma longa on liver function

Acronym

A study to evaluate the effect of a food containing Curcuma longa on liver function

Scientific Title

A study to evaluate the effect of a food containing Curcuma longa on liver function

Scientific Title:Acronym

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

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 Kawasaki Kengo

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 or person

Institute

House Wellness Foods Corporation Research and Development Institute

Institute

Department

Personal name



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

2017 Year 05 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

2014 Year 04 Month 12 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name