UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056993 |
|---|---|
| Receipt number | R000065131 |
| Scientific Title | A study of the suppressive effect of chocolate consumption on postprandial hyperglycemia. |
| Date of disclosure of the study information | 2025/02/13 |
| Last modified on | 2025/02/10 15:09:46 |
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Basic information
Public title
A study of the suppressive effect of chocolate consumption on postprandial hyperglycemia.
Acronym
A study of the suppressive effect of chocolate consumption on postprandial hyperglycemia.
Scientific Title
A study of the suppressive effect of chocolate consumption on postprandial hyperglycemia.
Scientific Title:Acronym
A study of the suppressive effect of chocolate consumption on postprandial hyperglycemia.
Region
| Japan |
Condition
Condition
Males and females aged 20 to 64 years old
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine whether the pre-consumption of the test food suppresses postprandial hyperglycemia in borderline subjects who exhibit hyperglycemia after food intake, by comparing the results with those from control food intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of blood glucose levels
Key secondary outcomes
Blood glucose levels
Serum insulin levels
Plasma pancreatic glucagon levels
Plasma GLP-1 levels
Plasma GIP levels
Serum free fatty acid levels
Matsuda index
Insulinogenic index
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1. Single intake of the test food.
2. Washout period more than two days.
3. Single intake of the control food.
Interventions/Control_2
1. Single intake of the control food.
2. Washout period more than two days.
3. Single intake of the test food.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Males and females aged 20 to 64 years old
(2)Subjects with borderline results in the oral glucose tolerance test from the first phase of the preliminary check (whose blood glucose levels meet any of the following criteria)
The range of fasting blood glucose levels is from 110 to 125 mg/dL.
The blood glucose level after 60 minutes of the oral glucose tolerance test is 180 mg/dL or higher.
The range of blood glucose levels after 120 minutes of the oral glucose tolerance test is from 140 to 199 mg/dL .
(3)Subjects showing hyperglycemia after the dietary load in the second phase of the preliminary check (with a blood glucose Cmax of 160 mg/dL or higher).
(4)Subjects whose fasting blood glucose levels are 125 mg/dL or lower in the first phase of the preliminary check.
(5)Subjects whose HbA1c levels are 6.4% or lower.
(6)Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who are having Food for Specified Health Uses (FOSHU), Foods with functional claims and/or health food, including supplements, (including suppression of blood glucose level elevation, etc.) which might affect this study, three times or more a week.
(2) Subjects who are taking medications (e.g., diabetes medications) that may affect this study.
(3) Subjects with severe hay fever symptoms who are taking oral medications, or who may take them during this study period (excluding those using only nasal sprays or eye drops).
(4) Subjects who are participating, participated within the last four weeks before this study, or are planning to participate another clinical study of medication or health food.
(5) Subjects who have extremely disheveled dietary habits.
(6) Subjects who have disheveled lifestyle (e.g., shift workers and night workers).
(7) Heavy drinkers
(8) Subjects who currently smoke, or have had a smoking habit from one year prior to the start of this study up to the present.
(9) Subjects who are undergoing a low-carbohydrate diet.
(10) Subjects with a BMI of 30.0 kg/m2 or higher in the first phase of the preliminary check.
(11) Subjects with abnormal thyroid function in the second phase of the preliminary check.
(12) Subjects who have been diagnosed as anemia or have subjective symptoms of anemia.
(13) Subjects who have past and present medical history of serious diseases of heart, liver, kidney, digestive organs, and/or thyroid gland, etc.
(14) Pregnant women, lactating women, or women who want to get pregnant during this study.
(15) Subjects who are allergic to drugs or foods.
(16)-(20) Subjects who have donated a lot of whole blood and/or blood components within the last 12 months prior to this study.
(21) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Midori |
| Middle name | |
| Last name | Natsume |
Organization
Meiji Holdings CO., Ltd.
Division name
Research Team 3 Wellness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5847
midori.natsume@meiji.com
Public contact
Name of contact person
| 1st name | Midori |
| Middle name | |
| Last name | Natsume |
Organization
Meiji Holdings CO., Ltd.
Division name
Research Team 3 Wellness Science Labs
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachioji, Tokyo
TEL
042-632-5847
Homepage URL
midori.natsume@meiji.com
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Meiji Holdings CO., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 13 | 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
| 2025 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065131
