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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023868
Receipt No. R000027311
Scientific Title Study on health effects of syrup
Date of disclosure of the study information 2016/09/01
Last modified on 2017/03/03

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Basic information
Public title Study on health effects of syrup
Acronym Study on health effects of syrup
Scientific Title Study on health effects of syrup
Scientific Title:Acronym Study on health effects of syrup
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effects of a 14-day ingestion 2 types of syrup on biochemical examination of blood, blood RNA, and fecal microflora in a randomized placebo-controlled crossover trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Liver function (ALT,AST,gammaGT,ALP,LD,T-Bil)
Key secondary outcomes ・Blood RNA analysis
・Fecal (intestinal) mocroflora analysis

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Test food (1 pack(15mL)/day) for 14 days > 14-day washout period > control food (1 pack(15mL)/day) for 14 days for 14 days
Interventions/Control_2 Control food (1 pack(15mL)/day) for 14 days > 14-day washout period > test food(1 pack(15mL)/day) for 14 days for 14 days
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1.Body mass index (BMI): from 23 to less than 30.
2.ALT: 26U/L or more in men, 18U/L or more in women.
3.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent.
4.Volunteers having screening test results judged to be appropriate for this study by investigator.
Key exclusion criteria 1.Patients with dyslipidemia or with diabetes under medical treatment or on the use of medicine.
2.Volunteers having severe history of the diseases (liver, kidney, hert, blood) judged to be inappropriate for this study.
3.Patients with liver diseases of alcoholic steatohepatitis, hepatitis C, hepatitis B, autoimmune hepatitis, cirrhosis, or liver cancer, etc. other than non-alcoholic fatty disease.
4.Volunteers received gastrectomy, enterectomy, or gastro-intestinal diseases, judged to be inappropriate for this study.
5.Volunteers with a risk of causing drug or food (especially maple syrup) allergic symptoms.
6.Volunteers with a risk of causing drug or food (especially maple syrup) allergic symptoms.
7.Women who are pregnant, might be pregnant, or are lactating.
8.Volunteers who participate in other clinical trials within the last one month prior to the current clinical trial.
9.Volunteers with any other medical reasons judged to be inappropriate by chief investigater.
10.Volunteers who habitually consume maple syrup.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Watanabe
Organization Niigata Universty of Pharmacy and Applied Life Sciences
Division name Laboratory of Clinical pharmacology
Zip code
Address 265-1, Higashijima, Akiha-ku, Niigata City
TEL 0250-25-5267
Email watanabe@nupals.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Niigata Bio-Research Park, Inc
Organization Niigata Bio-Research Park, Inc
Division name Business promotion division
Zip code
Address 316-2 Higashijima, Akiha-ku, Niigata, 956-0811, Japan
TEL 0250-25-1196
Homepage URL
Email goto@nbrp.co.jp

Sponsor
Institute Niigata Bio-Research Park, Inc
Institute
Department

Funding Source
Organization KANAGAWA ACADEMY OF SCIENCE AND TECHNOLOGY
Organization
Division
Category of Funding Organization Non profit foundation
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 09 Month 01 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
2016 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2017 Year 03 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027311

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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