UMIN-CTR Clinical Trial

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