UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050782 |
|---|---|
| Receipt number | R000057865 |
| Scientific Title | The effect of salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosylrutin, and phlorotannin on reduction of body fat/abdominal fat (visceral fat/subcutaneous fat)/body weight/waist circumference, BMI - A systematic review. |
| Date of disclosure of the study information | 2024/04/30 |
| Last modified on | 2023/04/07 10:43:15 |
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Basic information
Public title
The effect of salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosylrutin, and phlorotannin on reduction of body fat/abdominal fat (visceral fat/subcutaneous fat)/body weight/waist circumference, BMI - A systematic review.
Acronym
The effect of salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosyl rutin, and phlorotannin on reduction of body fat/abdominal fat (visceral fat/subcutaneous fat)/body weight/waist circumference, BMI - A systematic review.
Scientific Title
The effect of salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosylrutin, and phlorotannin on reduction of body fat/abdominal fat (visceral fat/subcutaneous fat)/body weight/waist circumference, BMI - A systematic review.
Scientific Title:Acronym
The effect of salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosylrutin, and phlorotannin on reduction of body fat/abdominal fat (visceral fat/subcutaneous fat)/body weight/waist circumference, BMI - A systematic review.
Region
| Japan |
Condition
Condition
Healthy adult volunteers with a BMI greater than or equal to 25 and less than 30 and not suffering from any diseases. We will exclude minors, pregnant women, and lactating women.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object of this systematic review is to evaluate the effect on reduction of body fat/abdominal fat (visceral fat/subcutaneous fat)/body weight/waist circumference, BMI of food containing salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosyl rutin, and phlorotannin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the effect on reduction of body fat/abdominal fat (visceral fat / subcutaneous fat) / body weight/waist circumference / BMI.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A systematic literature search is performed through scientific and clinical trial registries databases.
The selection criteria are as follows.
P: Healthy adult volunteers a BMI greater than or equal to 25 and less than 30 and not suffering from any diseases. We will exclude minors, pregnant women, and lactating women.
I: Intake the foods containing salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosyl rutin, and phlorotannin.
C: The control food is a placebo food that does not contain salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosyl rutin, and phlorotannin.
O: The primary outcome is the effect on reduction of body fat / abdominal fat (visceral fat / subcutaneous fat) / body weight / waist circumference / BMI.
Key exclusion criteria
The literature which does not meet the key inclusion criteria will be excluded. Intervention tests without a placebo intake group are excluded.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Seki |
Organization
FUJIFILM Corporation
Division name
Bio Science & Engineering Laboratories
Zip code
258-8577
Address
577, Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa
TEL
080-1339-9052
shinobu.seki@fujifilm.com
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Saito |
Organization
FUJIFILM Corporation
Division name
Bio Science & Engineering Laboratories
Zip code
258-8577
Address
577, Ushijima, Kaisei-Machi, Ashigarakami-gun, Kanagawa
TEL
080-2119-4836
Homepage URL
hitomi.saito@fujifilm.com
Sponsor or person
Institute
FUJIFILM Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yakujihou Marketing Jimusho Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
| 2024 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A systematic literature search is performed through scientific and clinical trial registries databases.
The selection criteria are as follows.
P: Healthy adult volunteers a BMI greater than or equal to 25 and less than 30 and not suffering from any diseases. We will exclude minors, pregnant women, and lactating women.
I: Intake the foods containing salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosyl rutin, and phlorotannin.
C: The control food is a placebo food that does not contain salacinol, indigestible dextrin, epigallocatechin gallate, monoglucosyl rutin, and phlorotannin.
O: The primary outcome is the effect on reduction of body fat / abdominal fat (visceral fat / subcutaneous fat) / body weight / waist circumference / BMI.
Management information
Registered date
| 2023 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057865
