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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023988
Receipt No. R000027617
Scientific Title A double-blind, randomized, placebo-controlled clinical study to investigate the effect of the food containing the polyphenols in Ashitaba (Angelica keiskei)
Date of disclosure of the study information 2016/09/10
Last modified on 2017/09/11

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Basic information
Public title A double-blind, randomized, placebo-controlled clinical study to investigate the effect of the food containing the polyphenols in Ashitaba (Angelica keiskei)
Acronym A clinical study to investigate the effect of the food containing polyphenols in Ashitaba
Scientific Title A double-blind, randomized, placebo-controlled clinical study to investigate the effect of the food containing the polyphenols in Ashitaba (Angelica keiskei)
Scientific Title:Acronym A clinical study to investigate the effect of the food containing polyphenols in Ashitaba
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of decreasing VFA (Visceral fat area) level by ingestion of the the food containing the polyphenols in Ashitaba (Angelica keiskei)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area, at 8 and 12 weeks after intake
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The food containing the polyphenols in Ashitaba (Angelica keiskei), 12 weeks
Interventions/Control_2 The food non-containing the polyphenols in Ashitaba (Angelica keiskei), 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Males and females equal to or more than 20 years and less than 65 years of age

2. Healthy males and females with no treatment

3. Subjects equal to or more than 25 and less than 30 kg/m^2 of BMI at the pre-study

4. Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria 1. Subjects who have marked impairment of liver, kidney, heart, lung, endocrine, metabolism, nerve, or consciousness, or have DM
2. Subjects who regularly use drugs, health foods, supplements which are suggested causal relationship from the study
3. Subjects who have allergy related to the test foods
4. Subjects who donated 200 mL or more of blood within a month prior to the study.
5. Heavy dinkers or heavy smokers
6. Subjects whose eating habits are extremely irregular
7. Pregnant and lactating female, or who wish to get pregnant during the study period.
8. Subjects who are ineligible due to physician's judgment.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fukuhara Ikuo
Organization Fukuhara Clinic
Division name Medical office
Zip code
Address 3-1-15 Shima-matsuhigashi machi, Eniwashi, Hokkaido, Japan
TEL 0123-36-8029
Email i-feniwa@gray.plala.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomita Shimpei
Organization New drug research center, Inc.
Division name Clinical Research Dept.
Zip code
Address 452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL 0123-34-0412
Homepage URL
Email s-tomita@ndrcenter.co.jp

Sponsor
Institute New drug research center, Inc.
Institute
Department

Funding Source
Organization Japan Bio Science Laboratory Co.,Ltd.
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 09 Month 10 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 07 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 12 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 09 Month 09 Day
Last modified on
2017 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027617

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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