UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010550
Receipt number R000012335
Scientific Title Effect of a late evening snack of amazake in patients with liver cirrhosis
Date of disclosure of the study information 2013/04/20
Last modified on 2014/10/20 13:59:19

* 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

Effect of a late evening snack of amazake in patients with liver cirrhosis

Acronym

A late evening snack of patients with liver cirrhosis

Scientific Title

Effect of a late evening snack of amazake in patients with liver cirrhosis

Scientific Title:Acronym

A late evening snack of patients with liver cirrhosis

Region

Japan


Condition

Condition

Liver cirrhosis

Classification by specialty

Gastroenterology Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of amazake, a traditional sweet Japanese beverage, as a late evening snack for cirrhotic patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Quality of life (QOL)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Each patient used a measuring cup and drank 150 mL of amazake (equivalent to 200 kcal) at bedtime, every night for 12 weeks. The study period comprised 12 weeks with evaluations at baseline (visit 1), 4 weeks (visit 2), 8 weeks (visit 3) and 12 weeks (visit 4).

Interventions/Control_2


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

Liver cirrhosis with sufficient food intake and a serum albumin concentration below 4.0 g/dL

Key exclusion criteria

1. Diabetes mellitus on medication for anti-diabetic drugs
2. Ongoing, self motivated consumption of late evening snacks
3. Hepatic encephalopathy, ascites, hepatocellular carcinoma (HCC)
4. Renal failure
5. Ongoing interferon therapy

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yumiko Nagao

Organization

Kurume University School of Medicine

Division name

Department of Digestive Disease Information & Research

Zip code


Address

Kurume, Fukuoka, 830-0011, Japan

TEL

0942-35-3311

Email

nagao@med.kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yumiko Nagao

Organization

Kurume University School of Medicine

Division name

Department of Digestive Disease Information & Research

Zip code


Address

Kurume, Fukuoka, 830-0011, Japan

TEL

0942-35-3311

Homepage URL

http://www.med.kurume-u.ac.jp/med/joho/

Email

nagao@med.kurume-u.ac.jp


Sponsor or person

Institute

Yumiko Nagao

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports, Science and Technology of Japan

Organization

Division

Category of Funding 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

久留米大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 20 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


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

2009 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 01 Day

Last follow-up date

2014 Year 10 Month 31 Day

Date of closure to data entry

2014 Year 10 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 04 Month 20 Day

Last modified on

2014 Year 10 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012335


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name