UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021308
Receipt number R000024576
Scientific Title Elucidation of effects of acute endurance exercise on novel peptide hormone
Date of disclosure of the study information 2016/03/04
Last modified on 2016/09/01 19:34:59

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Basic information

Public title

Elucidation of effects of acute endurance exercise on novel peptide hormone

Acronym

Elucidation of effects of acute endurance exercise on novel peptide hormone

Scientific Title

Elucidation of effects of acute endurance exercise on novel peptide hormone

Scientific Title:Acronym

Elucidation of effects of acute endurance exercise on novel peptide hormone

Region

Japan


Condition

Condition

Healthy males and females

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to evaluate whether acute endurance exercise modulates circulating peptide hormone level in healthy young and elderly subjects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Effects of acute endurance exercise on circulating peptide hormone level

Key secondary outcomes

Effects of acute endurance exercise on blood biochemical parameters


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Young participants undertook an acute aerobic exercise using cycle ergometer. Exercise intensity was 70% of maximal oxygen uptake, and exercise duration was 30 minutes.

Interventions/Control_2

Elderly participants undertook an acute aerobic exercise using cycle ergometer. Exercise intensity was 70% of maximal oxygen uptake, and exercise duration was 30 minutes.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy young subjects over 18 years old, and healthy elderly subjects over 60 years old

Key exclusion criteria

Subject who could not perform exercise and/or who have chronic diseases

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuru Higuchi

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-579-15 Mikajima, Tokorozawa, Saitama 359-1192

TEL

+81-4-2947-6745

Email

mhiguchi@waseda.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hirokazu Taniguchi

Organization

Waseda University

Division name

Graduate School of Sport Sciences

Zip code


Address

2-579-15 Mikajima, Tokorozawa, Saitama 359-1192

TEL

+81-4-2947-6745

Homepage URL


Email

hirokazu-t@akane.waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for JSPS Fellows. A Waseda University Grant. The Council for Science, Technology and Innovation, SIP, "Technologies for creating next-generation agriculture, forestry and fisheries".

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

早稲田大学 (Waseda University)


Other administrative information

Date of disclosure of the study information

2016 Year 03 Month 04 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/27453549

Number of participants that the trial has enrolled


Results

Twenty-eight subjects participated in the experiment, of whom 13 were excluded mainly because of a serum FGF21 level below the limit of detection. Thus, data from seven young (age: 18-22 years) and eight elderly male subjects (age: 62-69 years) were analysed. Participants were asked to perform a cycling exercise for 30 min at 70% maximal oxygen uptake, following carbohydrate intake. Blood samples were collected pre-exercise and 0 min, 30 min, 1 h, 3 h and 24 h after the cessation of exercise.
Higher serum FGF21 was observed in the elderly subjects group throughout the experiment (P < 0.05). There was no significant increase in serum FGF21 levels after the cessation of exercise, whereas serum FGF21 levels were significantly lower 24 h after the exercise compared with those pre-exercise, 0 min, 30 min and 1 h after the cessation of exercise in both groups (P < 0.01).

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

Main results already published

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 01 Day

Last follow-up date

2013 Year 12 Month 01 Day

Date of closure to data entry

2014 Year 03 Month 01 Day

Date trial data considered complete

2014 Year 07 Month 01 Day

Date analysis concluded

2016 Year 12 Month 23 Day


Other

Other related information



Management information

Registered date

2016 Year 03 Month 03 Day

Last modified on

2016 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024576


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name