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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039769
Receipt No. 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

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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
Email 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
Email misuzu-tanaka@matsutani.co.jp

Sponsor
Institute Sugiyama Jogakuen University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045354

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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