UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023781
Receipt number R000027394
Scientific Title Study on effects of a cereal derived processed product on postprandial energy metabolism.
Date of disclosure of the study information 2016/09/04
Last modified on 2017/06/20 16:32:00

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Basic information

Public title

Study on effects of a cereal derived processed product on postprandial energy metabolism.

Acronym

Study on effects of a cereal derived processed product on postprandial energy metabolism.

Scientific Title

Study on effects of a cereal derived processed product on postprandial energy metabolism.

Scientific Title:Acronym

Study on effects of a cereal derived processed product on postprandial energy metabolism.

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Endocrinology and Metabolism Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate effects of a cereal derived processed product on postprandial energy metabolism.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fat oxidation (Measuring time: before ingestion, and every 30 minutes until 4 hours later of the single ingestion of the test diet.)

Key secondary outcomes

Respiratory quotient, thermic effect of food(TEF), i. e., diet-induced thermogenesis(DIT), energy expenditure, and carbohydrate oxidation (Measuring time: before ingestion, and every 30 minutes until 4 hours later of the single ingestion of the test diet.)


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

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Single ingestion of the test diet "X" > Wash out more than 3days > Single ingestion of the test diet "Y" > Wash out more than 3days > Single ingestion of the test diet "Z"
(The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)

Interventions/Control_2

Single ingestion of the test diet "Y" > Wash out more than 3days > Single ingestion of the test diet "Z" > Wash out more than 3days > Single ingestion of the test diet "X"
(The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)

Interventions/Control_3

Single ingestion of the test diet "Z" > Wash out more than 3days > Single ingestion of the test diet "X" > Wash out more than 3days > Single ingestion of the test diet "Y"
(The control meal(code name;C-1),the test meal 1(code name;A-1), and the test meal 2 (code name;A-2). were assigned randomly to "X", "Y", and "Z" by the person in charge.)

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

25 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Aged between 24 and 59.
2)Informed consent provided
3)Able to follow the instructions of the study team

Key exclusion criteria

1)Serious disorder.
2)Regular hospital visit and medication intended to cure.
3)Daily excessive alcohol intake.
(Amount of alcohol intake >= 23 g/day)
4)Allergy against test food.
5)Person who can't accept to be accessed their medical records.
6)Person who can't answer a questionnaire about life situation and physical condition.
7)Person who are expecting pregnancy or lactation period.
8)Person who can't accept to disclose menstrual cycle.
9)Person who are considered inappropriate by the investigator, project leader, or medical doctors.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriyasu Oota

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7828

Email

oota.noriyasu@kao.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Junko Suzuki

Organization

Kao Corporation

Division name

R&D -Core Technology- Biological Science Research

Zip code


Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

0285-68-7687

Homepage URL


Email

suzuki.junko1@kao.co.jp


Sponsor or person

Institute

Kao Corporation

Institute

Department

Personal name



Funding Source

Organization

Kao Corporation

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

花王株式会社生物科学研究所(栃木県)


Other administrative information

Date of disclosure of the study information

2016 Year 09 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

We clarified efficacy of the cereal derived processed products on post prandial fat oxidation.

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

2016 Year 08 Month 24 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 05 Day

Last follow-up date

2017 Year 04 Month 06 Day

Date of closure to data entry

2017 Year 05 Month 15 Day

Date trial data considered complete

2017 Year 05 Month 15 Day

Date analysis concluded

2017 Year 06 Month 09 Day


Other

Other related information



Management information

Registered date

2016 Year 08 Month 26 Day

Last modified on

2017 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027394


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name