UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018522
Receipt number R000021438
Scientific Title Effect of high protein intakes on post-absorptive energy metabolism
Date of disclosure of the study information 2015/09/01
Last modified on 2016/08/01 10:11:42

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Basic information

Public title

Effect of high protein intakes on post-absorptive energy metabolism

Acronym

Effect of high protein intakes on post-absorptive energy metabolism

Scientific Title

Effect of high protein intakes on post-absorptive energy metabolism

Scientific Title:Acronym

Effect of high protein intakes on post-absorptive energy metabolism

Region

Japan


Condition

Condition

Adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to explore the relationship between protein intakes and postabsorptive energy thermogenesis

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diet induced thermogenesis (postabsorptive energy expenditure) is estimated using oxygen and carbon dioxide concentration in the expiration gas for 4 hours after the test breakfast was offered.

Key secondary outcomes

Blood glucose, appetite, autonomic nervous activity, uric nitrogen


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

On an experimental day, high protein breakfast (30% energy ratio) was offered.
At least 3 days wash out.
On the second experimental day, low protein breakfast(10% energy ratio) was offered.

Interventions/Control_2

On an experimental day, low protein breakfast (10% energy ratio) was offered.
At least 3days wash out.
On the second experimental day, high protein breakfast (30% energy ratio) was offered.

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

18 years-old <=

Age-upper limit

25 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy men assessed by perceived, clinical and biochemical parameters.

Key exclusion criteria

1) The person under medication and medical treatment
2) The person who are defined as lean or obese
3) The person who habitually perform intense physical activities

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukari KAWANO

Organization

Tokyo University of Agriculture

Division name

Department of Nutritional Sciences

Zip code


Address

Sakuraoka1-1-1, Setagaya, Tokyo

TEL

03-5477-2453

Email

y1kawano@nodai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukari KAWANO

Organization

Tokyo University of Agriculture

Division name

Department of Nutritional Sciences

Zip code


Address

Sakuraoka1-1-1, Setagaya, Tokyo

TEL

03-5477-2453

Homepage URL


Email

y1kawano@nodai.ac.jp


Sponsor or person

Institute

Tokyo University of Agriculture

Institute

Department

Personal name



Funding Source

Organization

Tokyo University of Agriculture

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

東京農業大学栄養科学科(東京都)
Department of Nutritional Sciences, Tokyo University of Agriculture


Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 01 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

2015 Year 07 Month 20 Day

Date of IRB


Anticipated trial start date

2015 Year 08 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2016 Year 11 Month 01 Day

Date analysis concluded

2017 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2015 Year 08 Month 02 Day

Last modified on

2016 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021438


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name