UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical trial of the effect of chocolate containing the plant extract on improving blood glucose level
Title of the study (Brief title)	A clinical trial of the effect of chocolate containing the plant extract on improving blood glucose level
Region	Japan

Condition
Condition	diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect on improving fasting blood glucose level by the administlation of chocolate containing the plant extract for 8 weeks
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood glucose, HbA1c and insulin level at each visit (-4W, 0W, 4W, 8W)
Key secondary outcomes	Blood triglyceride level, BMI and body component analysis at each visit (-4W, 0W, 4W, 8W)

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	20.4 g/day for 8 weeks as a replacement for snack between meals
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	35 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Fasting blood glucose level more than(>=)100 mg/dL 2) HbA1c(NGSP)level between(>=) 5.6% to (<)6.9% 3) Fasting serum triglyceride level (>=)100 mg/dL 4) BMI level more than(>=) 25 kg/square meter 5) Nonsmoker 6) Subject, upon briefing of the content of the present study, fully understands and agrees to its objective and is able to personally give written informed consent
Key exclusion criteria	1) Subject taking any diabetes treatment(pharmacotherapy, diet therapy, exercise therapy etc) 2) Subject regularly taking any FOSHU or health food which is capable of improving blood glucose level 3) Subject having no habit of having a snack between meals 4) Subject who ended participation in another clinical trial less than 3 months before and who is currently involved in another clinical trial 5) For female subjects: pregnancy or possibility of pregnancy, or intending to become pregnant during this clinical trial 6) Subject who should have diabetes treatment by the investigator's judgement 7) Subject having a possibility to cause allergy symptoms(especially allergy to soybean) related to clinical test 8) Subject determined unsuitable by the investigator
Target sample size	20

Research contact person
Name of lead principal investigator	Kajimoto Osami
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Medical Science on Fatigue
Address	1-4-3 Asahimachi, Abeno-ku, Osaka
TEL	06-6645-6171
Email	kajimoto@med.osaka-cu.ac.jp

Public contact
Name of contact person	Sugino Tomohiro
Organization	Soiken Inc.
Division name	R&D Division
Address	Senri Life Science Center 13F,1-4-2,Shinsenri-higashimachi, Toyonaka, Osaka
TEL	06-6871-8888
Homepage URL
Email	sugino@soiken.com

Sponsor
Institute	Soiken Inc.
Institute
Department

Funding Source
Organization	Sunstar Inc.
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	2014 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 21 Day
Anticipated trial start date	2014 Year 01 Month 25 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	2014 Year 01 Month 24 Day
Last modified on	2019 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015006