UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023820
Receipt number R000027438
Scientific Title Effect of supplement on respiratory metabolism. -a randomized, double-blind, placebo-controlled, cross-over study-
Date of disclosure of the study information 2016/08/30
Last modified on 2017/06/06 17:50:03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of supplement on respiratory metabolism. -a randomized, double-blind, placebo-controlled, cross-over study-

Acronym

Effect of supplement on respiratory metabolism.

Scientific Title

Effect of supplement on respiratory metabolism. -a randomized, double-blind, placebo-controlled, cross-over study-

Scientific Title:Acronym

Effect of supplement on respiratory metabolism.

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate the effect of ingestion of supplement on respiratory metabolism.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Fat oxidation

Key secondary outcomes

Volume of oxygen consumption (VO2)
Volume of carbon dioxide output (VCO2)
Respiratory quotient
Energy expenditure


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

Treatment

Type of intervention

Food

Interventions/Control_1

Measurement of respiratory metabolism in rest and exercise after single oral intake of supplement -> washout period (1 week) -> measurement of respiratory metabolism in rest and exercise after single oral intake of placebo

Interventions/Control_2

Measurement of respiratory metabolism in rest and exercise after single oral intake of placebo -> washout period (1 week) -> measurement of respiratory metabolism in rest and exercise after single oral intake of supplement

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

25 years-old <=

Age-upper limit

45 years-old >=

Gender

Male

Key inclusion criteria

1)Japanese males aged 25 to 45 years.
2)Healthy subjects who do not have some kind of disease treatment.
3)Subjects who have not performed regular exercise of one or more times per week within the past two years.
4)Subjects who eat three meals (breakfast, lunch, dinner) a day regularly.
5)BMI >=20 kg/m2 and <25kg/m2
6)Percent body fat >=10% and <=20%
7)Subjects who can eat only the provided meals from three days before until one day before of the measurement.
8)Subjects who can stay in the specific hotel a day before the measurement.
9)Subjects who received a sufficient explanation about the purpose and content of this study and have a consent ability and volunteered to participate in the understanding and can agree to this study participation in writing
10)Subjects who were deemed appropriate to participate in the study by the investigator.

Key exclusion criteria

1)Subjects who are undergoing medication suffer from some sort of disease.
2)Subjects who frequently become anemic symptoms.
3)Subjects who are might cause allergic symptoms to test foods or the provided meals, furthermore might cause serious allergic symptoms to the other foods or medicines.
4)Subjects who have a intake habit of continued medicines, quasi-drugs, food with health claims (food for specified health use), health foods and supplements such currently or within the past three months, furthermore going to their intake during the study period.
5)Subjects who have previous history or present illness of cardiovascular disease, nephritis, hepatitis, pancreatitis, and so on.
6)Subjects who have previous history of serious disability of liver, kidney, heart, lung, blood, and so on.
7)In principle, subjects who have comorbidity and previous history of digestive system.
8)Subjects who have previous history or present illness of epilepsy.
9)Subjects who systolic blood pressure is 140 mmHg or more, or diastolic blood pressure is greater than or equal to 90 mmHg at rest.
10)Subjects who are ingesting alcohol in excessive (alcohol in terms of 60 g or more per day).
11)Subjects who are a blood donation of more than 200 mL in the past one month, or more than 400 mL in the past three months.
12)Subject who have a smoking habit.
13)Subjects who are participating in other clinical trial or three months has not elapsed after joining other clinical trials.
14)Subjects who were deemed inappropriate to participate in the study by the investigator.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osami Kajimoto

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Medical Science on Fatigue

Zip code


Address

1-4-3, Asahi-machi, Abeno-ku, Osaka, Osaka

TEL

06-6645-6171

Email

kajimoto@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Aya Horiuchi

Organization

Soiken Inc.

Division name

R&D Division

Zip code


Address

Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka

TEL

06-6871-8888

Homepage URL


Email

horiuchi_aya@soiken.com


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

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

医療法人弘正会ふくだ内科クリニック(大阪府)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 30 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

Terminated

Date of protocol fixation

2016 Year 08 Month 20 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 16 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

2016 Year 08 Month 29 Day

Last modified on

2017 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027438


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name