UMIN-CTR Clinical Trial

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
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

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047255