UMIN-CTR Clinical Trial

Public title

Effects of food material (SIC-2018-03-KM)

Acronym

Effects of food material

Scientific Title

Effects of food material (SIC-2018-03-KM)

Scientific Title:Acronym

Effects of food material

Region

Japan

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Efficacy : physical endurance

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hiroshi Kawashima, Ph.D.

Organization

Suntory Global Innovation Center Ltd.

Division name

Research Department

Zip code

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan

TEL

050-3182-0628

Email

Hiroshi_Kawashima@suntory.co.jp

Name of contact person

1st name
Middle name
Last name	Keigo Horiuchi

Organization

Suntory Global Innovation Center Ltd

Division name

Research Department

Zip code

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

Institute

Suntory Global Innovation Center Ltd

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

08

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2018

Year

07

Month

21

Day

Date of IRB

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

Other related information

Registered date

2018

Year

07

Month

31

Day

Last modified on

2018

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038292