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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016365
Receipt No. R000019006
Scientific Title Effects of D-allulose (D-psicose), rare sugar, on postprandial energy expenditure in healthy humans
Date of disclosure of the study information 2015/01/30
Last modified on 2015/01/28

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Basic information
Public title Effects of D-allulose (D-psicose), rare sugar, on postprandial energy expenditure in healthy humans
Acronym Effects of D-allulose on postprandial energy expenditure in healthy humans
Scientific Title Effects of D-allulose (D-psicose), rare sugar, on postprandial energy expenditure in healthy humans
Scientific Title:Acronym Effects of D-allulose on postprandial energy expenditure in healthy humans
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined the effects of single ingestion of D-allulose (D-psicose), rare sugar, on postprandial energy expenditure in healthy humans.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Energy expenditure and substrate utilization assessed from respiratory gas analysis
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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of aspartame dissolved in water
Interventions/Control_2 Intake of D-allulose (D-psicose) dissolved in water
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
50 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy adults
2) Subjects giving written informed consent
Key exclusion criteria 1) Subjects who have allergic reaction to medicine
2) Subjects who smoke excessively and drink alcohol habitually, and whose eating habits are extremely irregular
3) Subjects who have liver dysfunction or renal dysfunction
4) Subjects who have history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture and intestinal resection
5) Midnight and irregular shift worker
6) Subjects who regularly use drugs such as constipation drugs, gastrointestinal drugs and intestinal drugs
7) Subjects who regularly have dietary fiber or oligosaccharides enriched food
8) Subjects who have diarrhea
9) Subjects who have diseases such as peptic ulcer, ulcerative colitis and irritable bowel syndrome
10) Subjects who are during pregnancy or nursing
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Okuma Kazuhiro
Organization Matsutani Chemical Industry Co., Ltd.
Division name Research and Development
Zip code
Address 5-3 Kita-Itami, Itami, Hyogo, Japan
TEL 072-771-2032
Email k-okuma@matsutani.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimura Tomonori
Organization Matsutani Chemical Industry Co., Ltd.
Division name Research and Development Department
Zip code
Address 5-3 Kita-Itami, Itami, Hyogo, Japan
TEL 072-771-2032
Homepage URL
Email tomonori-kimura@matsutani.co.jp

Sponsor
Institute Matsutani Chemical Industry Co., Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 松谷化学工業株式会社(兵庫県)
Matsutani Chemical Industry Co., Ltd. (Hyogo)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 30 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
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
2013 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 12 Day
Last follow-up date
2014 Year 03 Month 19 Day
Date of closure to data entry
2014 Year 03 Month 19 Day
Date trial data considered complete
2014 Year 03 Month 19 Day
Date analysis concluded
2014 Year 03 Month 19 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 28 Day
Last modified on
2015 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019006

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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