UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012939 |
|---|---|
| Receipt number | 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 17:44:31 |
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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
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
kajimoto@med.osaka-cu.ac.jp
Public contact
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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015006
