UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046683
Receipt number R000053253
Scientific Title The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.
Date of disclosure of the study information 2022/01/22
Last modified on 2022/01/20 17:18:12

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Basic information

Public title

The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.

Acronym

The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.

Scientific Title

The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.

Scientific Title:Acronym

The Acute Effects of Beetroot on Physiological Responses to Intermittent Exercise using Laboratory Based Setting among Recreational Athletes.

Region

Asia(except Japan)


Condition

Condition

supplementation

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

is to investigate the effect of acute dose of beetroot crystals (BRC) on exhaustive high-intensity intermittent exercise using laboratory-based setting.

Basic objectives2

Others

Basic objectives -Others

to determine the effect of blood glucose and lactate following acute dose of beetroot crystals (BRC) consumption.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Fatigue time of high intensity intermittent exercise

Key secondary outcomes

1. Blood pressure level
2. Blood lactate level
3. Blood glucose level


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

beetroot crystal

Interventions/Control_2

placebo (maltodextrin)

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

35 years-old >=

Gender

Male

Key inclusion criteria

1. physically healthy
2. normal BMI
3. weight range ;
4. free from injury.
5. male recreational collegiate soccer player (who regularly participate in competitive sport and participate in regular training sessions
6. recreational individual

Key exclusion criteria

1. smokers;
2. consistently on medication over the past 5 weeks;
3. blood transfusion recipient within one month of screening;
4. have history of treatment on leg muscles and/or have musculoskeletal problems,
5. has medical history of drugs or alcoholism and
6. undergoing medical surgery within 6 months of screening
7. has history of cardiovascular, pulmonary, or metabolic disease
8. history of allergy to beetroot

Target sample size

28


Research contact person

Name of lead principal investigator

1st name MAISARAH
Middle name
Last name MOHD SALEH

Organization

UNIVERSITI TEKNOLOGI MARA

Division name

FACULTY OF SPORTS SCIENCE & RECREATION

Zip code

26400

Address

Kampus Jengka Bandar Tun Abdul Razak Jengka Pahang, MALAYSIA

TEL

+60129308441

Email

sarahms@uitm.edu.my


Public contact

Name of contact person

1st name MAISARAH
Middle name
Last name MOHD SALEH

Organization

UNIVERSITI TEKNOLOGI MARA

Division name

FACULTY OF SPORTS SCIENCE & RECREATION

Zip code

26400

Address

Kampus Jengka Bandar Tun Abdul Razak Jengka Pahang, MALAYSIA

TEL

+60129308441

Homepage URL


Email

sarahms@uitm.edu.my


Sponsor or person

Institute

UNIVERSITI TEKNOLOGI MARA

Institute

Department

Personal name



Funding Source

Organization

UNIVERSITI TEKNOLOGI MARA

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

UNIVERSITI TEKNOLOGI MARA

Address

Kampus Jengka Bandar Tun Abdul Razak Jengka Pahang, MALAYSIA

Tel

+60133632005

Email

linoby@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

2022 Year 01 Month 22 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

28

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 01 Month 08 Day

Date of IRB

2020 Year 04 Month 25 Day

Anticipated trial start date

2022 Year 01 Month 22 Day

Last follow-up date

2022 Year 01 Month 22 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 01 Month 20 Day

Last modified on

2022 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053253


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name