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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032750
Receipt No. R000037350
Scientific Title Research on the effect of cacao product intake on postprandial hyperglycemia.
Date of disclosure of the study information 2019/03/31
Last modified on 2018/05/28

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Basic information
Public title Research on the effect of cacao product intake on postprandial hyperglycemia.
Acronym Effect of cacao product intake on postprandial hyperglycemia
Scientific Title Research on the effect of cacao product intake on postprandial hyperglycemia.
Scientific Title:Acronym Effect of cacao product intake on postprandial hyperglycemia
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the influence of intake of high cacao chocolate on changes in plasma glucose levels induced by oral glucose tolerance test.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma glucose levels
Key secondary outcomes Serum insulin levels, non-esterified free fatty acid concentration, glucagon concentration, GLP-1 concentration

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Oral glucose tolerance test after intake of high cacao chocolate
Interventions/Control_2 Only oral glucose tolerance test
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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria Subjects who competent to consent and give voluntary consent in writing with full understanding after receiving explanation of this study aim and contents.
Key exclusion criteria 1) Subjects who are under treatment for chronic disorders
2) Subjects whose HbA1c level is greater than 6.5% at the second screening
3) Subjects whose blood glucose level is greater than 126 mg/dl when fasting at the second screening
4) Subjects who are allergic to chocolate, milk, soybeans, wheat, beef, chicken, pork, salmon, crab, banana, apples, and oranges
5) Subjects with headache induced by intake of chocolates
6) Subjects who highly intake cacao products on a daily basis (high cacao chocolate: 70 g or more/ week, milk chocolate :140 g or more/ week)
7) Subjects taking medicines (such as hypoglycemic drugs) with function claims that potentially influence the outcome of this study on a daily basis, or those who intend to take these during this study
8) Subjects whose sexual cycle is unstable (persons with sex cycle other than 28 days)
9) Subjects who have participated in other clinical and monitoring studies within 1 month before screening or who plan to participate in other clinical trials after this clinical trial consent
10) Subjects who are pregnant, or plan to get pregnant during the study period
11) Subjects who are breast-feeding
12) Alcohol-heavy drinkers (drinkers with an average daily of over 60 g in terms of pure alcohol)
13) Subjects who are judged as ineligible by the examination director and doctors
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Arai
Organization The University of Shizuoka
Division name Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
Address 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL 054-264-5511
Email arai@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidekazu Arai
Organization The University of Shizuoka
Division name Laboratory of Clinical Nutrition and Management, School of Food and Nutritional Sciences
Zip code
Address 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL 054-264-5511
Homepage URL
Email arai@u-shizuoka-ken.ac.jp

Sponsor
Institute The University of Shizuoka
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 None
Name of secondary funder(s) None

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 浅井内科医院
福地皮ふ科クリニック
福地外科循環器医院

Other administrative information
Date of disclosure of the study information
2019 Year 03 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 09 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 28 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 05 Month 28 Day
Last modified on
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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