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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023820
Receipt No. 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

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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
Institute Soiken Inc.
Institute
Department

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
URL(English) https://upload.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


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