UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034606 |
|---|---|
| Receipt number | R000039450 |
| Scientific Title | The effects of novel chocolate on postprandial blood glucose level in healthy adults |
| Date of disclosure of the study information | 2018/12/24 |
| Last modified on | 2019/08/14 13:11:13 |
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Basic information
Public title
The effects of novel chocolate on postprandial blood glucose level in healthy adults
Acronym
The effects of dietary novel chocolate on postprandial blood glucose
Scientific Title
The effects of novel chocolate on postprandial blood glucose level in healthy adults
Scientific Title:Acronym
The effects of dietary novel chocolate on postprandial blood glucose
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We randomly allocated twelve subjects to administer any of the novel chocolate, the control chocolate, and the sugar 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 blood glucose level(Cmax) , and time to reach Cmax(Tmax)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
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
Single dose administration of 19.2 g of sugars in sugars period
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
| 29 | years-old | >= |
Gender
Male and Female
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 university.
3) Subjects with fasting blood glucose level within normal range between 70 mg/dL and 110 mg/dL using the first blood test
4) Subjects with systolic blood pressure under 140 mmHg and diastolic blood pressure under 90 mm Hg
5) Subjects with BMI above 18.5 kg/ m2-under 30 kg/ m2
6) Females who have a regular menstrual cycle, which is 25 to 38 days, and at the first test, who are from 14 days after the start of their menstruation to the next menstruation.
7) Non-smokers
Key exclusion criteria
1) Those who administer ''Food for Specified Health Use'', ''Foods with Function Claims'' or medicine to have effects on blood glucose metabolism.
2) Patients with diseases undergoing treatments or with medical history of severe diseases.
3) Patients who have severe diseases: diabetes, liver disease, kidney disease, heart disease (or persons who have history of these diseases).
4) Those who may suffer from allergy by administering milk, soybean, or cacao mass (chocolate).
5) Subjects who are in pregnancy, lactation.
6) Those who were included other clinical trials within one month before giving written informed consent, or during this study.
7) Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator or examination doctor.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Professor Toshihiro Miura |
Organization
Suzuka University of Medical Science
Division name
Faculty of Health Science
Zip code
Address
1001-1, Kishioka, Suzuka-city, Mie, 510-0293
TEL
059-383-8991
miura@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Natsume |
Organization
Meiji Co., Ltd.
Division name
Group2, Food Science & Technology Research Laboratories, R&D Division
Zip code
Address
1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919
TEL
042-632-5850
Homepage URL
midori.natsume@meiji.com
Sponsor or person
Institute
Suzuka University of Medical Science
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
鈴鹿医療科学大学（三重県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 24 | 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
11
Results
1) Analysis of all subjects revealed no significant difference between the control and test diets.
2) The test diet showed significant decrease in incremental area under the curve when compared with sucrose only while control diet did not change.
3) Compared to sucrose only, the chocolate with or without fructooligosaccharides significantly decreased blood glucose and Cmax.
Results date posted
| 2019 | Year | 08 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | 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 | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | 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
| 2018 | Year | 10 | Month | 23 | 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=R000039450
