UMIN-CTR Clinical Trial

Public title

Effects of edible plant oils on muscular strength augmentation in human

Acronym

Effects of edible plant oils on muscular strength augmentation in human

Scientific Title

Effects of edible plant oils on muscular strength augmentation in human

Scientific Title:Acronym

Effects of edible plant oils on muscular strength augmentation in human

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm the effect of edible plant oils on musclar strength augmentation and safety after the continuation intake in normal people.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Efficacy : Accentuation of the grip due to the edible plant oils at 12-week consumption.
Safety : Quality of the side effect

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The edible plant oils,twice a day,10g/day,12 weeks consumption.

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1)Healthy males and females.
2)Subjects who can make self-judgment and are voluntarily giving written informed consent.

Key exclusion criteria

1) Subjects who take continuous medical treatment.
2) The person who cannot come to the hospital in a designated institution on a designation day.
3) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
4) Subjects who have contracted or are contracting heart disease, liver disease, kidney disease and digestive disease.
5) diabetic patients.
6) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift
7) Subjects who have allergic reaction to drug medicine and food.
8) Subjects who donated 200 mL of blood and/or blood components within the last one month prior to the current study.
9) Male subjects who donated 400 mL of blood within the last three months prior to the current study.
10) Female subjects who donated 400 mL of blood within the last four months prior to the current study.
11) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
12) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
13) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks, or who are planning to participate in other clinical study.
14) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.

Target sample size

33

Name of lead principal investigator

1st name
Middle name
Last name	Norihito Murayama, Ph.D.

Organization

Suntory Global Innovation Center Ltd.

Division name

Innovation Development Department

Zip code

Address

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

TEL

070-2288-1190

Email

Norihito_Murayama@suntory.co.jp

Name of contact person

1st name
Middle name
Last name	Toshihide Suzuki

Organization

Suntory Global Innovation Center Ltd.

Division name

Innovation Development Department

Zip code

Address

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

TEL

070-2288-1143

Homepage URL

Email

Toshihide_Suzuki@suntory.co.jp

Institute

Suntory Global Innovation Center Ltd.

Institute

Department

Personal name

Organization

Suntory Global Innovation Center Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

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

2016

Year

01

Month

27

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

No longer recruiting

Date of protocol fixation

2015

Year

09

Month

07

Day

Date of IRB

Anticipated trial start date

2015

Year

09

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

01

Month

26

Day

Last modified on

2017

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023940