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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036928
Receipt No. R000042079
Scientific Title The Effect of Acute and Chronic Red Spinach Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Date of disclosure of the study information 2019/06/03
Last modified on 2019/06/04

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Basic information
Public title The Effect of Acute and Chronic Red Spinach Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Acronym The Effect of Acute and Chronic Red Spinach Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Scientific Title The Effect of Acute and Chronic Red Spinach Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Scientific Title:Acronym The Effect of Acute and Chronic Red Spinach Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Region
Asia(except Japan)

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to assess the effects of a single and repeated doses of red spinach extract over 16 days, on resting blood pressure, nitric oxide level and exercise performance in human adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Resting blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure)
2. Continuous and intermittent endurance exercise performance
Key secondary outcomes 1. Nitric oxide level
2. Renal function (Urea nitrogen, Creatine)
3. Blood glucose and blood lactate
4. Plasma sodium and potassium
5. Oxygen cost of exercise
6. Oxidant and antioxidant markers
7. Cognitive function

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
Food
Interventions/Control_1 4 grams per day of red spinach extract
Interventions/Control_2 Placebo capsule not containing red spinach extract
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
45 years-old >
Gender Male
Key inclusion criteria 1. Healthy adults

2. Free from injury.

3. Do not have any current or history of cardiovascular, metabolic, or pulmonary disease

4. No contraindication for blood sampling procedure.

5. Pass The Physical Activity Readiness Questionnaire (PAR-Q)
Key exclusion criteria 1. Smoker

2. Individual who consume any dietary supplements, quasi drugs or medicines within past 4 weeks.

3. On medication

4. Receiver of blood transfusion within 1 month prior to screening

5. Receiver of any investigational research agent prior to 30 days of experimental trial and individual who have a history of or current clinically significant disease.

6. Clinical population or an individual with heart/vascular related problem

7. Individual with the medical histories of alcoholism or drug dependence

8. Individual who have contraindication with high intensity exercise
Target sample size 15

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
Homepage URL https://seremban.uitm.edu.my/
Email linoby@uitm.edu.my

Sponsor
Institute Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Institute
Department

Funding Source
Organization Fundamental Research Grant Scheme, Ministry of Higher Education (Malaysia)
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Universiti Teknologi MARA (UiTM) Cawangan Negeri Sembilan

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, Seremban, Negeri Sembilan, Malaysia
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 03 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 18
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
2018 Year 11 Month 11 Day
Date of IRB
2018 Year 03 Month 17 Day
Anticipated trial start date
2019 Year 06 Month 03 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

Management information
Registered date
2019 Year 06 Month 03 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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