UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033789 |
|---|---|
| Receipt number | R000038535 |
| Scientific Title | The effects of dietary novel chocolate on postprandial blood glucose level in healthy adult men |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2019/08/14 13:36:51 |
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Basic information
Public title
The effects of dietary novel chocolate on postprandial blood glucose level in healthy adult men
Acronym
The effects of dietary novel chocolate on postprandial blood glucose
Scientific Title
The effects of dietary novel chocolate on postprandial blood glucose level in healthy adult men
Scientific Title:Acronym
The effects of dietary novel chocolate on postprandial blood glucose
Region
| Japan |
Condition
Condition
Healthy adult males
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We randomly allocated twelve subjects to administer either the novel chocolate or the control chocolate to investigate the postprandial blood glucose level, followed by a washout period. These subjects were then crossed over and received the alternative chocolate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level, the blood glucose areas under the curve (AUC), the maximum (Cmax) blood glucose level
Key secondary outcomes
Blood insulin level, the blood insulin areas under the curve (AUC), the maximum (Cmax) blood insulin level
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Single dose administration of 65 g of the novel chocolate in intervention period
Interventions/Control_2
Single dose administration of 65 g of the control chocolate in control period
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) All subjects voluntarily signed the informed consent after detailed description and understanding of this study
2) Those who belong to a particular company.
3) Subjects with fasting blood glucose level within normal range between 70 mg/dL and 110 mg/dL using the first blood test.
Key exclusion criteria
1) Those who administer 'Food for Specified Health Use','Foods with Function Clai s' or medicine to have effects on blood glucose metabolism.
2) Patients with diseases undergoing treatments or with medical history of severe diseases that required medication therapy.
3) Those who may suffer from allergy by administering cacao, milk or soybean.
4) Those who were included other clinical trials within one month before giving written informed consent, or during this study.
5) Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kurihara |
Organization
Kurihara Clinic, Nihonbashi, Tokyo
Division name
Kurihara Clinic, Nihonbashi, Tokyo
Zip code
Address
3-2-6 Nihonbashi, Chuoku, Tokyo 103-0027
TEL
03-3516-2200
kurihara@k-sarasara.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaya Kitamura |
Organization
Meiji Co., Ltd.
Division name
Clinical Study Group
Zip code
Address
1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919
TEL
042-632-5807
Homepage URL
takaya.kitamura@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
栗原クリニック 東京・日本橋（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
1) Blood glucose at 30 minutes after ingestion of the test diet was significantly lower than after ingestion of the control diet.
2) Plasma insulin levels at 30 and 60 minutes after ingestion of the test diet were also significantly lower than after ingestion of the control diet.
3) The change in area under the curve(delta AUC)of plasma insulin levels following ingestion of the test diet was significantly lower than that following ingestion of the control diet.
Results date posted
| 2019 | Year | 08 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 07 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 17 | Day |
Last modified on
| 2019 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038535
| Research Plan | |
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| Registered date | File name |
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