UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041499
Receipt number R000047377
Scientific Title The effects and value food intake on energy consumption
Date of disclosure of the study information 2020/08/21
Last modified on 2021/03/08 13:50:43

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Basic information

Public title

The effects and value food intake on energy consumption

Acronym

The effects and value food intake on energy consumption

Scientific Title

The effects and value food intake on energy consumption

Scientific Title:Acronym

The effects and value food intake on energy consumption

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects and value food intake on energy consumption

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of energy consumption
between the test and control groups

Key secondary outcomes

Comparison of energy consumption
between the test and standing position or walking
Fat consumption
Carbohydrate consumption
Height
Body weight
Muscle mass


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

4

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Test food

Interventions/Control_2

Control food

Interventions/Control_3

Comparison

Interventions/Control_4

Reference Comparison

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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Healthy person over 20 years of age
(2)A person who can refrain from strenuous exercise and drinking the day before the test date
(3)A person who have eaten gum before
and can take it in with no problem

Key exclusion criteria

(1)Pregnat,lactating
(2)A person who take metabolic treatments,medications or supplements
(3)A person who have food allergies

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Osawa

Organization

Lotte Co., Ltd

Division name

Central Laboratory, Kamukoto Research Department

Zip code

336-8601

Address

1-1, Numakage-3chome, Minami-ku, Saitama

TEL

048-837-0744

Email

Oosawa_Kenji@lotte.co.jp


Public contact

Name of contact person

1st name Naoya
Middle name
Last name Ooshima

Organization

Lotte Co., Ltd.

Division name

Central Laboratory, Kamukoto Research Department

Zip code

336-8601

Address

1-1, Numakage-3chome, Minami-ku, Saitama

TEL

048-837-0744

Homepage URL


Email

Ooshima_Naoya@lotte.co.jp


Sponsor or person

Institute

Lotte Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Lotte Co., Ltd.

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

Shiba Palace Clinic

Address

6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan

Tel

03-5408-1590

Email

jimukyoku@mail.souken-r.com


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



Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 21 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

20

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

2020 Year 08 Month 18 Day

Date of IRB

2020 Year 08 Month 17 Day

Anticipated trial start date

2020 Year 08 Month 25 Day

Last follow-up date

2020 Year 10 Month 16 Day

Date of closure to data entry

2020 Year 10 Month 16 Day

Date trial data considered complete

2020 Year 10 Month 16 Day

Date analysis concluded

2020 Year 11 Month 06 Day


Other

Other related information



Management information

Registered date

2020 Year 08 Month 21 Day

Last modified on

2021 Year 03 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047377


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name