UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041393 |
|---|---|
| Receipt number | R000047255 |
| Scientific Title | Investigation of the association between dietary nutrients intake and the regulatory factors governing brain health to exercise |
| Date of disclosure of the study information | 2020/08/12 |
| Last modified on | 2021/08/13 12:55:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of non-ketogenic low-carbohydrate diet plus interval exercise strategy on cerebral hemodynamics and neurotrophic factor responses: an investigation of physiological regulatory mechanisms (Part 1)
Acronym
Investigation of the association between dietary nutrients intake and the regulatory factors governing brain health to exercise
Scientific Title
Investigation of the association between dietary nutrients intake and the regulatory factors governing brain health to exercise
Scientific Title:Acronym
Impacts of nutritional state on brain health
Region
| Asia(except Japan) |
Condition
Condition
The healthy adults who routinely take exercise.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the association between dietary nutrients intake and the regulatory factors governing cerebral hemodynamic health to exercise
Basic objectives2
Others
Basic objectives -Others
Association between nutritional state and cerebral hemodynamic health
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cerebral blood flow/hemodynamic profiles and nutritional state
Key secondary outcomes
1. Fatigue related scales (VAS, modified Borg scale)
2. Heart rate/cardiovascular responses
3. Energy expenditure during exercise
4. Cognitive and exercise related biochemical examinations of blood
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
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
90
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
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
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
| 2020 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
Unpublished (data will be available upon request)
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished (data will be available upon request)
Number of participants that the trial has enrolled
90
Results
The study was proposed to enroll 90 participants, and 90 participants (90 males; age: 20-60 years) have signed written informed consent forms, and the last participant completed the informed consent forms of this the study by 2021/01/25. The main objective of the study was to investigate the association between dietary nutrients intake and the regulatory factors governing brain health to exercise. All study participants had no adverse reactions during all trials.
Results date posted
| 2021 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 90 males (age: 20-60 years) participated in this study and their baseline cerebral hemodynamic parameters and nutritional states were examined (CHO/Fat/Protein percentage).
Participant flow
The study was proposed to enroll 90 participants, and 90 participants (90 males; age: 20-60 years) have signed written informed consent forms, and the last participant completed the informed consent forms of this the study by 2021/01/25, and three of the participants did not complete the study due to their personal reasons (schedule did not match their time).
Adverse events
All participants had no reports of adverse responses during all trials.
Outcome measures
Cerebral blood flow/hemodynamic profiles and nutritional state
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation items include cerebral blood flow/hemodynamic profiles, dietary nutritional state, cognitive performance, glycemic metabolites analysis, cognitive/exercise related biochemical examinations of blood.
Management information
Registered date
| 2020 | Year | 08 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047255
