UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044958
Receipt number R000051364
Scientific Title Influence of ingestion of structured lipids on endurance exercise performance:a randomized, double-blind, placebo-controlled, parallel-group trial
Date of disclosure of the study information 2021/08/07
Last modified on 2022/07/28 07:14:18

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Basic information

Public title

Influence of ingestion of structured lipids on endurance exercise performance:a randomized, double-blind, placebo-controlled, parallel-group trial

Acronym

Effect of structured lipids on endurance exercise performance

Scientific Title

Influence of ingestion of structured lipids on endurance exercise performance:a randomized, double-blind, placebo-controlled, parallel-group trial

Scientific Title:Acronym

Effect of structured lipids on endurance exercise performance

Region

Japan


Condition

Condition

Endurance exercise performance

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the influence of structured lipids for endurance exercise performance.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Duration time of exercise performance

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

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Tested material: structured lipids
Dosage: 4.38g/day
Duration: 8 weeks

Interventions/Control_2

Tested material: physical mix oil
Dosage: 4.38g/day
Duration: 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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

Healthy male subjects

Key exclusion criteria

Subjects with
/resistance training more than five times a week for a year /no resistance training or exercise during over a year /serious liver, kidney, heart, respiratory, endocrine or metabolic diseases/ scheduled for surgery during this study/ administration of regular medication/ regular administration of supplements which affect this study / food allergies/ participation of other clinical trial during this study/ restriction of exercise/ any reason in the opinion of the lead principal investigator not to take part in this study

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Eisuke
Middle name
Last name Ochi

Organization

Hosei University

Division name

Faculty of Bioscience and Applied Chemistry

Zip code

1848584

Address

3-7-2 Kajino, Koganei, Tokyo

TEL

042-387-6337

Email

ochi@hosei.ac.jp


Public contact

Name of contact person

1st name Eisuke
Middle name
Last name Ochi

Organization

Hosei University

Division name

Faculty of Bioscience and Applied Chemistry

Zip code

1848584

Address

3-7-2 Kajino, Koganei, Tokyo

TEL

042-387-6337

Homepage URL


Email

ochi@hosei.ac.jp


Sponsor or person

Institute

Hosei University

Institute

Department

Personal name



Funding Source

Organization

Nippon Suisan Kaisha Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Teikyo Heisei University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo Heisei University

Address

2-51-4 Higashiikebukuro, Toshimaku, Tokyo

Tel

03-5843-3152

Email

rec@thu.ac.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

2021 Year 08 Month 07 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

Completed

Date of protocol fixation

2021 Year 07 Month 20 Day

Date of IRB

2021 Year 08 Month 05 Day

Anticipated trial start date

2021 Year 08 Month 08 Day

Last follow-up date

2021 Year 11 Month 30 Day

Date of closure to data entry

2022 Year 01 Month 10 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 07 Month 26 Day

Last modified on

2022 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051364


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name