UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032750 |
|---|---|
| Receipt number | 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 | 2020/07/10 14:20:38 |
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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
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
arai@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
The University of Shizuoka
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
None
Name of secondary funder(s)
None
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
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 28 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037350
