UMIN-CTR Clinical Trial

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