UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036903
Receipt number R000042056
Scientific Title The Role of Fitness Status in the Performance-Enhancing Effects of Nitrate Supplementation: Meta-analysis and Meta-regression Analysis
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/30 23:22:38

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Basic information

Public title

The Role of Fitness Status in the Performance-Enhancing Effects of Nitrate Supplementation: Meta-analysis and Meta-regression Analysis

Acronym

The Role of Fitness Status in the Performance-Enhancing Effects of Nitrate Supplementation: Meta-analysis and Meta-regression Analysis

Scientific Title

The Role of Fitness Status in the Performance-Enhancing Effects of Nitrate Supplementation: Meta-analysis and Meta-regression Analysis

Scientific Title:Acronym

The Role of Fitness Status in the Performance-Enhancing Effects of Nitrate Supplementation: Meta-analysis and Meta-regression Analysis

Region

Asia(except Japan)


Condition

Condition

Trained and untrained

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to clarify the potential of training status to influence the exercise performance enhancing effect of nitrate supplementation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Improvement in exercise performance

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The studies fulfilling the following criteria were included in the analysis: 1. Study manuscript written in English; 2. Presented with data necessary to analyze the effect estimates (including baseline Vo2max mean value); 3. controlled experimental design; 4. healthy and non-clinical adult human participants (excluding elderly population); 5. Exercise in normobaric environment.

Key exclusion criteria

Exclusion criteria were as follows: 1. Study manuscript not written in English; 2. Not presented with data necessary to analyze the effect estimates; 3. Absent of controlled experimental design; 4. Clinical population; 5. Children and elderly population

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Adam
Middle name
Last name Linoby

Organization

Universiti Teknologi MARA

Division name

Faculty of Sports Science and Recreation

Zip code

70300

Address

UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri Sembilan, Malaysia

TEL

+60133632005

Email

linoby@uitm.edu.my


Public contact

Name of contact person

1st name Adam
Middle name
Last name Linoby

Organization

Universiti Teknologi MARA

Division name

Faculty of Sports Science and Recreation

Zip code

70300

Address

UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri

TEL

0133632005+60133632005

Homepage URL

https://seremban.uitm.edu.my/

Email

linoby@uitm.edu.my


Sponsor or person

Institute

Faculty of Sports Science and Recreation, Universiti Teknologi MARA

Institute

Department

Personal name



Funding Source

Organization

Fundamental Research Grant Scheme, Ministry of Higher Education (Malaysia)

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Malaysia


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Faculty of Sports Science and Recreation, Universiti Teknologi MARA

Address

UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3

Tel

+606-6342409

Email

shari0971@uitm.edu.my


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

2019 Year 06 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

500

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

2017 Year 12 Month 01 Day

Date of IRB

2017 Year 01 Month 01 Day

Anticipated trial start date

2017 Year 12 Month 31 Day

Last follow-up date

2020 Year 12 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Electronic data-bases (Pubmed, ProQuest and SPORTDiscus) searches were conducted up to December 2017.


Management information

Registered date

2019 Year 05 Month 30 Day

Last modified on

2019 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042056


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name