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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010550
Receipt No. 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

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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
Institute Yumiko Nagao
Institute
Department

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
URL(English) https://upload.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


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