UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034156
Receipt No. 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 (Ver. 4)

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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
Email 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
Email yihungliao.henry@gmail.com

Sponsor
Institute National Taipei University of Nursing and Health Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038937