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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033580
Receipt No. R000038292
Official scientific title of the study Effects of food material (SIC-2018-03-KM)
Date of disclosure of the study information 2018/08/03
Last modified on 2018/07/31

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Basic information
Official scientific title of the study Effects of food material (SIC-2018-03-KM)
Title of the study (Brief title) Effects of food material

Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the effects of food material on physical endurance with aerobic training.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy : physical endurance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
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 2
Purpose of intervention Prevention
Type of intervention
Food Behavior,custom
Interventions/Control_1 Aerobic training + Food material
8 weeks
Interventions/Control_2 Aerobic training + placebo
8 weeks
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
40 years-old <=
Age-upper limit
69 years-old >=
Gender Male
Key inclusion criteria (1) Healthy males who are 40-69 years old
(2) The subjects who do not have exercise habit.
(3) The subjects who do not have problem on daily physical activity.
(4) The subject who can come to the facility on the designated day.
(5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) The subjects who have motor system disease or its previous history affecting this test.
(2) The subjects who have a recurrence risk for motor system disease by the exercise.
(3) The subjects who are on a diet or have a plan.
(4) The subjects who have experience of high intensity exercise.
(5) The heavy alcohol drinker.
(6) The smoker.
(7) The subjects whose BMI is less the 18.5 or over 25
(8) The subjects whose systolic pressure >160 mmHg or diastolic pressure >100 mmHg
(9) Subjects who are judged as unsuitable for the study by the result of clinical examination and physical examination.
(10) The subjects whose systolic pressure <90 mmHg.
(11) The Subjects who donated over 200ml whole blood within 4 weeks.
(12) The Subjects who donated over 400ml whole blood within 12 weeks.
(13) The subjects whose blood was collected more than 1200 mL within the last 12 months when the amount of blood sampling in the current study is added.
(14) The subjects who are participating in other clinical studies, or who finished clinical study within 4 weeks
(15) The subjects who are applicable to following items
a) The subjects with disease on heart, liver, kidney or other organs complication.
b) The subjects with a previous history of disease on circulatory organs
c) The subjects who have respiratory disease
d) The subjects who are contracting diabetes.
e) The subjects with test food allergy
(16) The subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 28

Research contact person
Name of lead principal investigator Hiroshi Kawashima, Ph.D.
Organization Suntory Global Innovation Center Ltd.
Division name Research Department
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL 050-3182-0628
Email Hiroshi_Kawashima@suntory.co.jp

Public contact
Name of contact person Keigo Horiuchi
Organization Suntory Global Innovation Center Ltd
Division name Research Department
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL 050-3182-0573
Homepage URL
Email Keigo_Horiuchi@suntory.co.jp

Sponsor
Institute Suntory Global Innovation Center Ltd
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

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
2018 Year 08 Month 03 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 21 Day
Anticipated trial start date
2018 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 31 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038292

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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