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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036534
Receipt No. R000041620
Scientific Title The effects of food ingestion while walking on energy expenditure and fat oxidation
Date of disclosure of the study information 2019/04/22
Last modified on 2019/06/22

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Basic information
Public title The effects of food ingestion while walking on energy expenditure and fat oxidation.
A placebo-controlled, Randomization, single blind, cross over trial
Acronym The effect of food ingestion while walking on energy expenditure
Scientific Title The effects of food ingestion while walking on energy expenditure and fat oxidation
Scientific Title:Acronym The effect of food ingestion while walking on energy expenditure
Region
Japan

Condition
Condition healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluate the effect of energy, fat oxidation and walking index when ingesting test foods during walking
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subject's exhalation gas index while walking

Key secondary outcomes Subject's walking speeds, strides, steps, heart rates and electrical activity of muscles while walking

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food
Interventions/Control_1 Ingestion of 2 test foods while 15 minutes walking -> break
-> Ingestion of 2 control foods while 15 minutes walking
Interventions/Control_2 Ingestion of 2 control foods while 15 minutes walking -> break
-> Ingestion of 2 test foods while 15 minutes walking
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
70 years-old >
Gender Male and Female
Key inclusion criteria (1) Healthy males and females from 20 to 69 years of age
(2)Individuals having the BMI between 25 and less than 30
(3) Subjects giving written informed consent
Key exclusion criteria (1) Individuals who are pregnant or lactation
(2) Individuals who are systolic blood pressure over 140 mmHg or diastolic blood pressure is over 90 mmHg
(3) Individuals who are fasting blood sugar level over 110 mg/dl
(4) Individuals who have the symptoms of orthopedic or central nervous
(5) Individuals who have the activity time (walking, housework, exercise, etc.) less than 60 minutes in daily life
(6) Individuals who have problems or require an assistive device while walking
(7) Individuals presenting known food allergy in connection with the exam
(8) individuals who have history of heart disease
Target sample size 46

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Miyashita
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 04-2947-6774
Email m.miyashita@waseda.jp

Public contact
Name of contact person
1st name Masashi
Middle name
Last name Miyashita
Organization Waseda University
Division name Faculty of Sport Sciences
Zip code 359-1192
Address 2-579-15 Mikajima, Tokorozawa, Saitama
TEL 04-2947-6774
Homepage URL
Email m.miyashita@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Lotte Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Waseda University
Address 1-104 Totsuka-cho, shinjuku-ku, Tokyo
Tel 03-5272-1639
Email rinri@list.waseda.jp

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 04 Month 22 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
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 Open public recruiting
Date of protocol fixation
2019 Year 04 Month 15 Day
Date of IRB
2019 Year 04 Month 15 Day
Anticipated trial start date
2019 Year 04 Month 23 Day
Last follow-up date
2019 Year 12 Month 13 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 04 Month 17 Day
Last modified on
2019 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041620

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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