UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039769 |
|---|---|
| Receipt number | R000045354 |
| Scientific Title | Effect of chocolate containing D-allulose on postprandial lipidemia |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2020/03/11 13:21:47 |
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Basic information
Public title
Effect of chocolate containing D-allulose on postprandial lipidemia
Acronym
Effect of chocolate containing D-allulose on postprandial lipidemia
Scientific Title
Effect of chocolate containing D-allulose on postprandial lipidemia
Scientific Title:Acronym
Effect of chocolate containing D-allulose on postprandial lipidemia
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effest of chocolate containing D-allulose on postprandial lipidemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Triglyceride until 6 hours after consumption
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of chocolate containing sucrose
Interventions/Control_2
Intake of chocolate containing sucrose and 1.8g D-allulose
Interventions/Control_3
Intake of chocolate containing sucrose and 3.6g D-allulose
Interventions/Control_4
Intake of chocolate containing sucrose and 12.5g D-allulose
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)Healthy adults
2)Subjects with regular ovarian cycles
3)Subjects with apolipoprotein E phenotype 3/3
Key exclusion criteria
1)Subjects with apparent acute or chronic illnesses
2)Subjects who have any medications and dietary supplements.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Michitaka |
| Middle name | |
| Last name | Naito |
Organization
Sugiyama Jogakuen University
Division name
School & Graduate School of Life Studies
Zip code
464-8662
Address
17-3, Hoshigaoka-motomachi, Chikusa-ku, Nagoya, Japan
TEL
0527814603
naito@sugiyama-u.ac.jp
Public contact
Name of contact person
| 1st name | Misuzu |
| Middle name | |
| Last name | Tanaka |
Organization
Matsutani Chemical Industry Co., Ltd.
Division name
Reseach and Development
Zip code
664-8508
Address
5-3 Kita-Itami, Itami, Hyogo, Japan
TEL
0727712052
Homepage URL
misuzu-tanaka@matsutani.co.jp
Sponsor or person
Institute
Sugiyama Jogakuen University
Institute
Department
Personal name
Funding Source
Organization
Matsutani Chemical Industry 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
the Institutional Review Board of Sugiyama Jogakuen University School of Life Studies
Address
17-3, Hoshigaoka-motomachi, Chikusa-ku, Nagoya, Japan
Tel
0527814603
naito@sugiyama-u.ac.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
| 2020 | Year | 03 | Month | 12 | 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
8
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
To submit a paper during preparation
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
| 2017 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045354
