UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031529
Receipt number R000036002
Scientific Title Effect of Solubilized medium-chain triacylglycerols on energy metabolism
Date of disclosure of the study information 2018/03/01
Last modified on 2018/03/26 17:22:10

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Basic information

Public title

Effect of Solubilized medium-chain triacylglycerols on energy metabolism

Acronym

Effect of Solubilized medium-chain triacylglycerols on energy metabolism

Scientific Title

Effect of Solubilized medium-chain triacylglycerols on energy metabolism

Scientific Title:Acronym

Effect of Solubilized medium-chain triacylglycerols on energy metabolism

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to investigate the effects of the test meal on exercise performance and energy metabolism of healthy adults have regular exercise habits.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Blood sugar level, blood ketone body, lactic acid level, respiratory quotient, the mileage

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

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

Interventions/Control_1

To take a supplement, if necessary with water.

Interventions/Control_2

To take a placebo, if necessary with water.

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

20 years-old <=

Age-upper limit

39 years-old >=

Gender

Male

Key inclusion criteria

1.Japanese male aged 20-39 at the screening visit.
2.Healthy adults.(no serious disease by self-report).
3.Those who do regular exercise habits.
4.Those who are able to sign an informed consent, after fully informed the purpose and contents of the study.
5.Those who are able to come to the hospital on the day of the study.

Key exclusion criteria

1.Those with serious or progressive diseases and symptoms, those with motor function disorders.
2.Currently under medications.
3.Severely damaged exerciser such as bone fracture, tendon rupture, muscle tear in the past year.
4.Those who are stopped to exercise by a doctor.
5.Those who do weight training everyday.
6.Smokers or those who quit smoking for less than 1 year.
7.Those who drink alcohol on the day before the study visit.
8.Those who with an abnormality in the blood test value at the time of screening, except for judged by the Principal doctor as physiological fluctuation range.
9.Those who are participated in other clinical trials within a month before the screening test.
10.Those who with any food or medicine allergies.
11.Those who judged to be inappropriate for participating in the study by Principal Investigator (or other doctor).

Target sample size

4


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuki Kamioka

Organization

NOF CORPORATION

Division name

FUNCTIONAL FOODS RESEARCH LABORATORY 3GROUP

Zip code


Address

3-3 CHIDORI-CHO,KAWASAKI-KU,KAWASAKI,KANAGAWA ,JAPAN

TEL

044-281-2502

Email

yuki_kamioka@nof.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuki Kamioka

Organization

NOF CORPORATION

Division name

FUNCTIONAL FOODS RESEARCH LABORATORY 3GROUP

Zip code


Address

3-3 CHIDORI-CHO,KAWASAKI-KU,KAWASAKI,KANAGAWA ,JAPAN

TEL

044-281-2502

Homepage URL


Email

yuki_kamioka@nof.co.jp


Sponsor or person

Institute

NOF CORPORATION

Institute

Department

Personal name



Funding Source

Organization

NOF CORPORATION

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 03 Month 01 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

2018 Year 01 Month 23 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 01 Day

Last modified on

2018 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036002


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name