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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012939
Receipt No. R000015006
Scientific Title A clinical trial of the effect of chocolate containing the plant extract on improving blood glucose level
Date of disclosure of the study information 2014/07/31
Last modified on 2019/01/28

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Basic information
Public title A clinical trial of the effect of chocolate containing the plant extract on improving blood glucose level
Acronym A clinical trial of the effect of chocolate containing the plant extract on improving blood glucose level
Scientific Title A clinical trial of the effect of chocolate containing the plant extract on improving blood glucose level
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Kajimoto Osami
Organization Osaka City University Graduate School of Medicine
Division name Department of Medical Science on Fatigue
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka
TEL 06-6645-6171
Email kajimoto@med.osaka-cu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Sugino Tomohiro
Organization Soiken Inc.
Division name R&D Division
Zip code
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)

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
2014 Year 07 Month 31 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
2013 Year 12 Month 21 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000015006

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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