UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051076 |
|---|---|
| Receipt number | R000058238 |
| Scientific Title | Measurement of blood index fluctuation after eating sugarless confectionery. |
| Date of disclosure of the study information | 2023/05/19 |
| Last modified on | 2023/11/16 10:14:14 |
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Basic information
Public title
Measurement of blood components fluctuation after eating sugarless confectionery (study B).
Acronym
Effect of sugarless confectionery on blood index (study B).
Scientific Title
Measurement of blood index fluctuation after eating sugarless confectionery.
Scientific Title:Acronym
Measurement of blood index fluctuation after eating sugarless confectionery.
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 product.
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 IAUC
Key secondary outcomes
Insulin level, Insulin level IAUC
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved 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 50 g of sugarless chocolate (B).
Interventions/Control_2
Single intake 50 g of normal chocolate (B).
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females between the ages of 20 and 64 years old.
Key exclusion criteria
(1) Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function.
(2) Subjects who routinely use medicines and health foods related to blood glucose level and glucose metabolism.
(3) Subjects who have possibilities for emerging allergy related to the study.
(4) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(5) Subjects who have under treatment.
(6) Subjects who have a history of pancreatic disease, endocrine disease (including diseases related to the thyroid gland), liver disease, gastric resection and other diseases that may cause diabetes / glucose metabolism disorders.
(7) Subjects who have a disease requiring continuous medication, or serious medical history who needed medication.
(8) Subjects whose measured value and clinical laboratory tests on preliminary examination are significantly out of the standard values.
(9) Subjects who have a habit of skipping food on a daily basis, or those who have an extremely irregular diet.
(10) Subjects who are engaged in day / night shift work, midnight work, or irregular life habits.
(11) Subjects who have been diagnosed with insomnia or sleep apnea, or who have extremely irregular sleep habits.
(12) Subjects who plan to travel abroad during the study, or those who plan to go on a domestic business trip, domestic trip, or return to their hometown for the three days before the examination date of intake period I or intake period II.
(13) Subjects who have participated in other clinical study within the last one month prior to the current study or have participated in other clinical studies.
(14) Subjects who intend to become pregnant or lactating.
(15) 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.
(16) Others who are judged by the investigator to be inappropriate as subjects.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Ando |
Organization
Lotte Co., Ltd.
Division name
Central Laboratory
Zip code
336-8601
Address
1-1, Numakage-3chome, Minami-ku, Saitama
TEL
048-837-0187
andou_tomonori@lotte.co.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Yoshimura |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Trial Planning Section 1
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo, Japan
TEL
080-1193-3234
Homepage URL
yoshimura.kaori265@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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
| 2023 | Year | 05 | Month | 19 | 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
36
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
| 2023 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 18 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058238
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