UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000033789
Receipt No. 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 (Ver. 3)

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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
Email 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
Email takaya.kitamura@meiji.com

Sponsor
Institute Meiji Co., Ltd.
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038535