UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034156 |
|---|---|
| Receipt number | R000038937 |
| Scientific Title | The role of nutrition timing system in the interactive effects of interval training and amino acids supplementation on metabolic fitness, cerebral hemodynamics, and cognitive functions (Part 1) |
| Date of disclosure of the study information | 2018/09/15 |
| Last modified on | 2019/10/05 13:38:25 |
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Basic information
Public title
The role of nutrition timing system in the interactive effects of interval training and amino acids supplementation on metabolic fitness, cerebral hemodynamics, and cognitive functions (Part 1)
Acronym
Impacts of varied interval exercise models on cerebral hemodynamic, metabolic, and cognitive profiles
Scientific Title
The role of nutrition timing system in the interactive effects of interval training and amino acids supplementation on metabolic fitness, cerebral hemodynamics, and cognitive functions (Part 1)
Scientific Title:Acronym
Impacts of varied interval exercise models on cerebral hemodynamic, metabolic, and cognitive profiles
Region
| Asia(except Japan) |
Condition
Condition
The healthy adults who routinely take exercise.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the effects of interval exercise models with varied intensity setting on the changes in cerebral blood flow regulation and cognitive functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebral blood flow/hemodynamic profiles, cognitive task performance,glycemic metabolites analysis, cognitive/exercise related biochemical examination of blood.
Key secondary outcomes
1. Fatigue related scales (VAS, modified Borg scale)
2. Heart rate response
3. Energy expenditure during exercise
4. Cognitive and exercise related biochemical examinations of blood
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
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Sedentary resting control (participant sitting for resting during entire experiment period)
Interventions/Control_2
Interval exercise model #1: complete 5 cycles of interval exercise (each cycle consists of 4 min at 90% individual maximal effort/3 min at 60% individual maximal effort) plus 1-hour post-exercise recovery
Interventions/Control_3
Interval exercise model #2: complete 5 cycles of interval exercise (each cycle consists of 4 min at 75% individual maximal effort/3 min at 60% individual maximal effort) plus 1-hour post-exercise recovery
Interventions/Control_4
Interval exercise model #3: complete 5 cycles of interval exercise (each cycle consists of 2 min at 90% individual maximal effort/2 min at 75% individual maximal effort/3 min at 60% individual maximal effort) plus 1-hour post-exercise recovery
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who routinely take exercise.
3. Subjects who have no clinical skeletomuscular problems within 12-weeks prior to the study.
4. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects with respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who can't take exercise tolerance by bicycle ergometer.
3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
4. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
5. Subjects who have cognitive disorder or who have possibility of the disorder.
6. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yi-Hung |
| Middle name | |
| Last name | Liao |
Organization
National Taipei University of Nursing and Health Sciences
Division name
Department of Exercise and Health Science
Zip code
11219
Address
No.365, Ming-Te Road, Peitou District,, Taipei City
TEL
+886228227101
yihungliao.henry@gmail.com
Public contact
Name of contact person
| 1st name | Yi-Hung |
| Middle name | |
| Last name | Liao |
Organization
National Taipei University of Nursing and Health Sciences
Division name
Department of Exercise and Health Science
Zip code
11219
Address
No.365, Ming-Te Road, Peitou District,
TEL
+886228227101
Homepage URL
yihungliao.henry@gmail.com
Sponsor or person
Institute
National Taipei University of Nursing and Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ministry of Science and Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Taiwan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee
Address
10087 No.18, Si-yuan Street, Zhong-zheng District, Taipei , Taiwan (R.O.C.) 2-3F of Si-yuan Hall
Tel
886233669956
nturec@ntu.edu.tw
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
National Taipei University of Nursing and Health Sciences (Taipei)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 15 | 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
14
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Results summary (minimal-maximal values): blood glucose (90%-60% HIIE=baseline: 74-134 mg/dl);(90%-75%-60% HIIE=baseline: 65-113 mg/dl);(75%-60% HIIE=baseline: 86-136 mg/dl);(Rest=baseline: 86-125 mg/dl).
Blood lactate: (90%-60% HIIE=baseline: 0.6-2.7 mM); (90%-75%-60% HIIE=baseline: 0.5-1.7 mM); (75%-60% HIIE=baseline: 0.6-5.8 mM); (Rest=baseline: 0.8-1.7 mM).
Participant flow
The study received 14 consents from (13 males, 1 female; 20-37 years old), which met the data analysis needs. The first enrolled participant in this study signed the consent form on 2018/09/16, the last one participants signed the consent form on 2019/02/25. Among the participants, one female participants was unable to follow the experimental schedule to withdraw from the study due to the menstrual cycle and sickness. The remaining thirteen participants (average age: 25.2 yrs old) completed 4 different exercise patterns/rest tests, and all participants had no reports of adverse responses during all trials.
Adverse events
All participants had no reports of adverse responses during all trials.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study received 14 consents froms from the participants. The first enrolled participant in this study signed the consent form on 2018/09/16, the last one participants signed the consent form on 2019/02/25.
Management information
Registered date
| 2018 | Year | 09 | Month | 15 | Day |
Last modified on
| 2019 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038937
