UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034606
Receipt No. 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 (Ver. 3)

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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
Email 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
Email midori.natsume@meiji.com

Sponsor
Institute Suzuka University of Medical Science
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039450