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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034213
Receipt No. R000039004
Scientific Title A clinical study to evaluate to the effects of D-psicose (D-allulose) on respiratory metabolism (meal tolerance test)
Date of disclosure of the study information 2019/11/04
Last modified on 2018/09/20

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Basic information
Public title A clinical study to evaluate to the effects of D-psicose (D-allulose) on respiratory metabolism (meal tolerance test)
Acronym A clinical study to evaluate to the effects of D-psicose on respiratory metabolism (meal tolerance test)
Scientific Title A clinical study to evaluate to the effects of D-psicose (D-allulose) on respiratory metabolism (meal tolerance test)
Scientific Title:Acronym A clinical study to evaluate to the effects of D-psicose on respiratory metabolism (meal tolerance test)
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of intake of beverage containing D-psicose on respiratory metabolism: a randomized, double-blind, placebo-controlled, crossover study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fat oxidation
Key secondary outcomes Respiratory quotient
Energy expenditure

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Measurement of respiratory metabolism in exercise after single intake of beverage containing D-psicose 30 minutes before meal tolerance -> washout period (1 week) -> measurement of respiratory metabolism in exercise after single intake of placebo 30 minutes before meal tolerance
Interventions/Control_2 Measurement of respiratory metabolism in exercise after single intake of placebo 30 minutes before meal tolerance -> washout period (1 week) -> measurement of respiratory metabolism in exercise after single intake of beverage containing D-psicose 30 minutes before meal tolerance
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
40 years-old >
Gender Male
Key inclusion criteria 1) Healthy males whose age of 20 years or more and less than 40 years
2) BMI >=18.5 kg/m2 and <25.0 kg/m2
3) Percent body fat >=10.0% and <25.0%
4) Subjects who have not regular exercise of two and more times per week
5) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent
Key exclusion criteria 1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects having a medical history of chest pain or syncope
3) Subjects having an abnormality in the electrocardiogram
4) Subjects having a subjective symptom of low back pain, arthralgia or lumber hernia, disease of lower limbs, palpitations
5) Subjects who have the possibility of developing allergic symptoms by the test food
6) Subjects who take regularly Foods for Specified Health Uses, Foods with Function Claims labeled, medicines and quasi-drugs having the effect on respiratory metabolism
7) Subjects who have a smoking habit
8) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
9) Subjects who is currently taking part in another clinical study
10) Subjects deemed unsuitable by the investigator
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuka Kishimoto
Organization Matsutani Chemical Industry Co., Ltd.
Division name Research Institute Section 1 Group 2
Zip code
Address 5-3 , Kitaitami , Itami-shi , Hyogo
TEL 072-771-2052
Email yuka-kishimoto@matsutani.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Aya Horiuchi
Organization Soiken Inc.
Division name R&D Division
Zip code
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email horiuchi_aya@soiken.com

Sponsor
Institute Soiken Inc.
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
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 医療法人弘正会ふくだ内科クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 04 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 21 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 20 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039004

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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