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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039303
Receipt No. R000044828
Scientific Title Verification of the effect of consumption of food containing plant extract on fat consumption. A placebo-controlled, randomized, double-blind, cross-over trial.
Date of disclosure of the study information 2020/01/29
Last modified on 2021/03/17

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Basic information
Public title Verification of the effect of consumption of food containing plant extract on fat consumption. A placebo-controlled, randomized, double-blind, cross-over trial.
Acronym Verification of the effect of consumption of food containing plant extract on fat consumption.
Scientific Title Verification of the effect of consumption of food containing plant extract on fat consumption. A placebo-controlled, randomized, double-blind, cross-over trial.
Scientific Title:Acronym Verification of the effect of consumption of food containing plant extract on fat consumption.
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of intake of plants extract on promoting fat consumption at rest.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Respiratory quotient
Key secondary outcomes Energy consumption
Oxygen consumption
Lipid oxidation
Carbohydrate oxidation

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 Test food with plants extract - washout period - placebo food
Interventions/Control_2 Placebo food - washout period - test food with plants extract
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
60 years-old >
Gender Male
Key inclusion criteria (1)Males and Females from 20 to 59 years of age(from 20 to 30 kg/m2)
(2) Subjects giving written informed consent
Key exclusion criteria (1)Individuals who cannot stop the consumption of health foods (including foods for specified health uses and foods with functional claims) and medicines that affect carbohydrate metabolism, lipid metabolism, and body fat
(2)Individuals who may develop allergies related to the test
(3) Smoker
(4)Individuals who have high blood pressure, cardiovascular disease, diabetes, endocrine disease
(5)Individuals who have had drug dependence or alcohol dependence in the past or present
(6)Individuals who participate in tests that consume other foods or use drugs, who participate in tests that apply cosmetics, drugs, or who are willing to participate
(7)Individuals judged by the investigator or investigator to be inappropriate for participation in the study
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Ando
Organization Lotte Co., Ltd.
Division name Central Laboratory , Food material development section
Zip code 336-8601
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0187
Email andou_tomonori@lotte.co.jp

Public contact
Name of contact person
1st name Tomonori
Middle name
Last name Ando
Organization Lotte Co., Ltd.
Division name Central Laboratory , Food material development section
Zip code 336-8601
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0187
Homepage URL
Email andou_tomonori@lotte.co.jp

Sponsor
Institute Lotte Co., Ltd.
Institute
Department

Funding Source
Organization Lotte Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shiba Palace Clinic institutional review board
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel 03-5408-1590
Email jimukyoku@mail.souken-r.com

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
2020 Year 01 Month 29 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 14
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
2020 Year 01 Month 23 Day
Date of IRB
2020 Year 01 Month 23 Day
Anticipated trial start date
2020 Year 01 Month 30 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 04 Month 03 Day
Date trial data considered complete
2020 Year 04 Month 08 Day
Date analysis concluded
2020 Year 04 Month 10 Day

Other
Other related information

Management information
Registered date
2020 Year 01 Month 29 Day
Last modified on
2021 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044828

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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