UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039303 |
|---|---|
| Receipt number | 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 08:34:15 |
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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
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
andou_tomonori@lotte.co.jp
Sponsor or person
Institute
Lotte Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044828
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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