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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036693
Receipt No. R000041804
Scientific Title A Study on the Effect of Food Containing Plant Extract on Energy Metabolism -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2019/05/10
Last modified on 2019/05/09

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Basic information
Public title A Study on the Effect of Food Containing Plant Extract on Energy Metabolism
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym A Study on the Effect of Food Containing Plant Extract on Energy Metabolism
Scientific Title A Study on the Effect of Food Containing Plant Extract on Energy Metabolism
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym A Study on the Effect of Food Containing Plant Extract on Energy Metabolism
Region
Japan

Condition
Condition No
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of food containing plant extract on energy metabolism
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Energy metabolism
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 Treatment
Type of intervention
Food
Interventions/Control_1 Food containing plant extract, 8 weeks consumption
Interventions/Control_2 Food not containing plant extract, 8 weeks consumption
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
30 years-old <=
Age-upper limit
40 years-old >
Gender Male
Key inclusion criteria (1) Healthy males aged 30 to 39 years-old.
(2) Subjects whose BMI are 20 or over and under 25.
(3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subjects who contract chronic disease and are under treatment.
(2) Subjects who have a history of and/or contract serious diseases (eg, liver and kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease).
(3) Subjects who are judged to correspond to diabetic type, have hypertension and/or have symptoms of anemia by the screening tests.
(4) Subjects who have declared allergic reaction to ingredients of test foods.
(5) Subjects who can't stop using medicines, quasi-drugs, supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting energy metabolism during test periods.
(6) Subjects who have excessive alcohol intake more than approximately 60 g/day of pure alcohol equivalent or a habit of drinking not less than 5 days a week.
(7) Subjects who have a history of and/or contract drug addiction and/or alcoholism.
(8) Subjects who can't stop drinking from 2 days before each measurement.
(9) Subjects who have a habit of smoking.
(10) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption.
(11) Subjects who are judged as unsuitable for the current study by the investigator through the screening tests.
(12) Subjects who are shiftworker and/or midnight-shift worker.
(13) Subjects who have regular exercise not less than 2 days a week.
(14) Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
(15) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(16) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Satoru
Middle name
Last name Suzuki
Organization Shinagawa Season Terrace Health Care Clinic
Division name Medical examination and treatment management family chief director
Zip code 108-0075
Address 1-2-70, Konan, Minato-ku, Tokyo
TEL 03-3452-3382
Email satoru_suzuki@sempos.or.jp

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Komori
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7, Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization TOYO SHINYAKU Co., Ltd.
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 Ethical Committee of Nihonbashi Cardiology Clinic
Address 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel 03-5641-4133
Email niho-jimucho@well-sleep.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
2019 Year 05 Month 10 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 11 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041804

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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