UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016365 |
|---|---|
| Receipt number | 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 17:24:37 |
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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
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
tomonori-kimura@matsutani.co.jp
Sponsor or person
Institute
Matsutani Chemical Industry Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
