UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045667 |
|---|---|
| Receipt number | R000052130 |
| Scientific Title | Measurement of blood index fluctuation after eating sugarless chocolate. -2 step crossover single blind controlled trial- |
| Date of disclosure of the study information | 2021/10/18 |
| Last modified on | 2022/04/11 08:08:49 |
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Basic information
Public title
Measurement of blood components fluctuation after eating sugarless chocolate.
Acronym
Effect of sugarless chocolate on blood index.
Scientific Title
Measurement of blood index fluctuation after eating sugarless chocolate. -2 step crossover single blind controlled trial-
Scientific Title:Acronym
Measurement of blood index fluctuation after eating sugarless chocolate.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure of blood index fluctuation after eating sugarless chocolate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose level, blood glucose level AUC
Key secondary outcomes
Insulin, neutral fat, active GLP-1
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single intake 40 g of sugarless chocolate.
Interventions/Control_2
Single intake 40 g of normal chocolate.
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 whose age is no less than 20, less than 65 years old at the time of consent acquisition who have no problem with blood sugar level
2) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects suffering from serious renal disease, liver disease, heart disease, respiratory disease, endocrine disease, and other metabolic diseases
2) Subjects who take regularly medicines that may affect blood glucose levels
3) Subjects who cannot stop taking supplements, health foods (including food for specified health use, foods with functional claims) that may affect blood glucose levels during the test period
4) Subjects with a history of gastrointestinal diseases and gastrointestinal surgery that affect digestion and absorption (excluding appendicitis)
5) Subjects weighing less than 40 kg
6) Subjects who have food allergies
7) Subjects with a history of drug dependence, alcohol dependence, or current medical history
8) Subjects who are pregnant, are willing to become pregnant during the test period, may be pregnant, are breastfeeding
9) Subjects who cannot stop drinking from 2 days before each test
10) Subjects who have been diagnosed with anemia by screening tests and are not suitable for frequent blood sampling
11) Subjects who have collected more than 200 mL of blood within 1 month or donated more than 400 mL of blood within 3 months from the date of consent acquisition
12) Subjects who are participating in the test of ingesting other foods or using medicines, the test of applying cosmetics and medicines, those who have participated in other clinical trials within one month of obtaining consent, and those who are willing to participate
13) Others who are judged by the investigator to be inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 12-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Yoshikawa |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
Shibaura Omodaka Building 7F, 1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
LOTTE 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
Ethical Committee of Kobuna Orthopedics clinic
Address
5-656-17 Joutou-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
日本橋循環器科クリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 18 | 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
32
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
| 2021 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 06 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 06 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 05 | Day |
Last modified on
| 2022 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052130
