UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034213
Receipt number 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 2023/03/27 10:05:25

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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 or person

Institute

Soiken Inc.

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2018 Year 07 Month 21 Day

Date of IRB

2018 Year 07 Month 21 Day

Anticipated trial start date

2018 Year 09 Month 22 Day

Last follow-up date

2018 Year 11 Month 04 Day

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

2023 Year 03 Month 27 Day



Link to view the page

Value
https://center6.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