UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036962 |
|---|---|
| Receipt number | R000042109 |
| Scientific Title | The Effect of Acute and Chronic L-Citrulline Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults |
| Date of disclosure of the study information | 2019/06/04 |
| Last modified on | 2019/06/04 17:52:55 |
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Basic information
Public title
The Effect of Acute and Chronic L-Citrulline Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Acronym
The Effect of Acute and Chronic L-Citrulline Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Scientific Title
The Effect of Acute and Chronic L-Citrulline Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Scientific Title:Acronym
The Effect of Acute and Chronic L-Citrulline 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 L-Citrulline 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
| Medicine | Other |
Interventions/Control_1
6 grams per day of L-citrulline
Interventions/Control_2
Placebo capsule not containing L-citrulline
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 recreationally active males
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
8
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
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
+60133632005
Homepage URL
https://seremban.uitm.edu.my/
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
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
Tel
+606-6342409
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 | 04 | 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 | 12 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 04 | 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 | 04 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042109
