UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A double-blind, randomized, placebo-controlled clinical study to investigate the effect of the food containing the polyphenols in Ashitaba (Angelica keiskei)
Title of the study (Brief title)	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	Fukuhara Ikuo
Organization	Fukuhara Clinic
Division name	Medical office
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	Tomita Shimpei
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027617