UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024142
Receipt No. R000027753
Scientific Title Effect of the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14)
Date of disclosure of the study information 2016/09/24
Last modified on 2020/01/07

* 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 the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14)
Acronym Effect of the Drink Containing Plant Extract on Fat Metabolism
Scientific Title Effect of the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14)
Scientific Title:Acronym Effect of the Drink Containing Plant Extract on Fat Metabolism
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines the effect of the drink containing plant extract on fat metabolism during exercise.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes [1]Fat oxidation during exercise (test period I, test period II)
Key secondary outcomes *Secondary outcomes
[1]Energy expenditure during exercise (screening, test period I, test period II)
[2]Respiratory quotient during exercise (screening, test period I, test period II)
[3]Fasting energy expenditure (screening, test period I, test period II)
[4]Fasting fat oxidation (screening, test period I, test period II)
[5]Fasting respiratory quotient (screening, test period I, test period II)
[6]Blood examination (screening, test period I, test period II)
[7]Urine analysis (screening, test period I, test period II)

*Safety
[1]Respiratory gas examination except indexes of primary and secondary outcomes (screening, test period I, test period II)
[2]Blood examination (screening, test period I, test period II)
[3]Urine analysis (screening, test period I, test period II)
[4]Adverse event (each day during the test period)
[5]Diagnosis by doctors (each day during the test period)

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 [1]Oral intake of the test product (containing plant extract, 1 bottle in a day; 2 weeks)
[2]Observation
[3]Washout (2 weeks)
[4]Oral intake of the placebo product (not containing plant extract, 1 bottle in a day; 2 weeks)
[5]Observation
Interventions/Control_2 [1]Oral intake of the placebo product (not containing plant extract, 1 bottle in a day; 2 weeks)
[2]Observation
[3]Washout (2 weeks)
[4]Oral intake of the test product (containing plant extract, 1 bottle in a day; 2 weeks)
[5]Observation
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
50 years-old >
Gender Male
Key inclusion criteria [1]Healthy males aged 20-49 years
[2]Individuals whose BMIs are over 20 and under 25
[3]Individuals who are healthy and have no disease
[4]Individuals judged appropriate for the study by the principal
[5]Individuals who can come to the designated venue for this study and be inspected
[6]Individuals who are in the habit of walking or running and are capable of stopping these habits and conducting an exercise by ergometer
[7]Individuals whose written informed consent have been obtained
Key exclusion criteria [1]Individuals using medical products
[2]Individuals who are sensitive to a test product
[3]Individuals who will plan to go long term business trip or trip (more than 6 consecutive days) during test period
[4]Individuals who are shift worker
[5]Individuals who are difficult to participate due to have a liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases
[6]Individuals with serious anemia
[7]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30mg/day)
[8]Individuals who are a smoker
[9]Individuals who will be not capable of stopping to intake green tea, coffee and other beverage containing caffeine during the test period
[10]Individuals who participated or will participate in other clinical studies
[11]Individuals who have been medicated or operated in the past 2 months
[12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements (individuals who will stop to ingesting these foods at the begging of the test can participate into the study)
[13]Individuals who have experience of bad feeling by blood sampling
[14]Individuals who donated blood over 200mL in the past 1 month or have a plan to donate blood over 200mL.
[15]Individuals who cannot intake test foods constantly during the test period
[16]Individuals who cannot record a dietary record (for 6 days)
[17]Individuals who deny to disclose past their own medical examination record
[18]Individuals who cannot agree current informed consent
[19]Individuals judged inappropriate for the study by the principal
Target sample size 22

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Ono
Organization Medical Corporation Wakei-kai Medics Hongo Clinic
Division name Director
Zip code 113-0023
Address 2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN
TEL 03-6801-9761
Email info@tes-h.co.jp

Public contact
Name of contact person
1st name Ryoma
Middle name
Last name Shimizu
Organization TES Holdings Co. Ltd
Division name Administrative Department of Clinical Trials
Zip code 110-0013
Address 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL 03-6801-8480
Homepage URL
Email info@tes-h.co.jp

Sponsor
Institute TES Holdings Co. Ltd
Institute
Department

Funding Source
Organization Kao 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 The Ethics Committee of the Oriental Ueno Detection Center
Address Ueno Taito-ku Tokyo 110-0005, JAPAN
Tel 03-5816-0711
Email jimukyoku@tes-h.co.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
2016 Year 09 Month 24 Day

Related information
URL releasing protocol N/A
Publication of results Unpublished

Result
URL related to results and publications N/A
Number of participants that the trial has enrolled 22
Results There was no significant difference in the primary outcome.
Results date posted
2019 Year 12 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Healthy males.
Participant flow 22 participants were enrolled in this study. One participant dropped out before starting to consume the test (or placebo) products. 21 participants who completed this study were incorporated into the analyses.
Adverse events No adverse events related to the test products were reported.
Outcome measures Fat oxidation during exercise.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 31 Day
Date of IRB
2016 Year 08 Month 30 Day
Anticipated trial start date
2016 Year 09 Month 26 Day
Last follow-up date
2016 Year 11 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 23 Day
Last modified on
2020 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027753

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.