UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041627
Receipt number R000047420
Scientific Title Effects of a single bout of upper or lower body exercise on metabolic response
Date of disclosure of the study information 2020/09/01
Last modified on 2021/10/30 22:07:18

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Basic information

Public title

Effects of a single bout of upper or lower body exercise on energy metabolism in healthy young male

Acronym

Effects of a single bout of upper or lower body exercise on metabolism in young male

Scientific Title

Effects of a single bout of upper or lower body exercise on metabolic response

Scientific Title:Acronym

Effects of upper or lower body exercise on metabolism

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effects of upper or lower body exercise on postprandial metabolism in healthy male.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood triglyceride

Key secondary outcomes

Anthropometry, blood pressure, expired gas, cardiovascular responses, other blood lipid and carbohydrate parameters, and hormonal markers.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participants consume the test meal followed by upper body exercise, then blood pressure, expired gas, cardiac responses are measured for the evaluation of carbohydrate and lipid metabolism.

Interventions/Control_2

Participants consume he test meal followed by lower body exercise, then blood pressure, expired gas, cardiac responses are measured for the evaluation of carbohydrate and lipid metabolism.

Interventions/Control_3

Participants consume the test meal followed by rest, then blood pressure, expired gas, cardiac responses are measured for the evaluation of carbohydrate and lipid metabolism.

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

29 years-old >=

Gender

Male

Key inclusion criteria

1. Age between 20 and 29 years old
2. Not taking any medications and dietary supplements
3. No surgical diseases
4. No smoker
5. A participant who performed weight changes plus or minus 3 kg in the past three months and who has no intention to weight loss during the study.
6. A participant who can consume the test food in the study

Key exclusion criteria

1. Not age between 20 and 29 years old
2. A participant who takes medications and dietary supplements
3. A participant who has surgical diseases
4. Smoker
5. A participant who performed weight changes plus or minus 3 kg in the past three months and who has an intention to weight loss during the study.
6. A participant who cannot consume the test food in the study

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Masashi
Middle name
Last name Miyashita

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

359-1192

Address

2-579-15 Mikajima,Tokorozawa, Saitama

TEL

04-2947-6774

Email

m.miyashita@waseda.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Miyashita

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

359-1192

Address

2-579-15 Mikajima,Tokorozawa, Saitama

TEL

04-2947-6774

Homepage URL


Email

m.miyashita@waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Waseda Univesity

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Waseda Univesity

Address

1-104 Totsuka-cho, shinjuku-ku, Tokyo

Tel

03-5272-1639

Email

rinri@list.waseda.jp


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 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

2020 Year 06 Month 17 Day

Date of IRB

2020 Year 09 Month 03 Day

Anticipated trial start date

2020 Year 09 Month 07 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 09 Month 01 Day

Last modified on

2021 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047420


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name