UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039251 |
|---|---|
| Receipt number | R000044756 |
| Scientific Title | A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass - Randomized placebo-controlled double-blind parallel group comparison study - |
| Date of disclosure of the study information | 2021/05/23 |
| Last modified on | 2021/07/02 11:39:03 |
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Basic information
Public title
A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass
- Randomized placebo-controlled double-blind parallel group comparison study -
Acronym
A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass
Scientific Title
A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass
- Randomized placebo-controlled double-blind parallel group comparison study -
Scientific Title:Acronym
A study to evaluate the effects of foods containing plant-derived ingredients on body fat mass
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and efficacy of the test food on body fat mass including visceral fat during 12-week supplementation in healthy adult men and women classified as pre-obese or obese class I
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
abdominal total fat area, BMI
Key secondary outcomes
body weight, body fat percentage, abdominal visceral fat area, abdominal subcutaneous fat area, waist circumference, hip circumference, W/H ratio, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, fasting blood glucose, HbA1c
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one capsule (680 mg) of the test food orally at dinner for 12 weeks
Interventions/Control_2
Take one capsule (680 mg) of the placebo food orally at dinner for 12 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged of 20-64 years at the date of the informed consent
2) Subjects whose BMI values are 27.0 or more and less than 32.0
3) Subjects who have received a sufficient explanation of the purpose and content of the study, have the consent ability and good understandings, and have agreed voluntarily in writing to participate in the study
Key exclusion criteria
1) Subjects who regularly use pharmaceuticals
2) Subjects who cannot stop taking supplements and health foods (including foods for specified health use and foods with functional claims) that may affect something for the test in the study period
3) Subjects who have a history of severe kidney disease, heart disease, respiratory disease, endocrine disease, diabetes, etc., and undergoing treatment for them (excluding transient treatment such as colds)
4) Subjects who declare some allergies to the components of the test product
5) Subjects who have a history of drug/alcohol dependence or a current medical history
6) Subjects who have metal by surgery and others in measurement areas for CT scan and dual scan
7) Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators
8) Claustrophobic
9) Subjects who plan to travel overseas or have a long business trip during this study period
10) Subjects who cannot take the test food as instructed
11) Subjects who cannot maintain daily living habits, such as shift workers and late-night workers
12) Smokers exceeding 20 cigarettes per day, subjects who regularly take more than 40 g per day of alcohol
13) Subjects who are currently pregnant or lactating, or who plan to become pregnant in the study period
14) Subjects who are currently participating in other clinical studies that take or apply other foods, pharmaceuticals, cosmetics, or chemicals, who have participated in other clinical studies within the past month from the date of consent, or who plan to participate in others
15) Subjects judged as unsuitable for this study by the principal investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Iwao |
| Middle name | |
| Last name | Funahashi |
Organization
KANEKA CORPORATION
Division name
Pharma & Supplemental Nutrition Solutions Vehicle
Zip code
107-6028
Address
1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL
050-3133-6397
Iwao.Funahashi@kaneka.co.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO CORPORATION
Division name
Department of Facility Management
Zip code
105-0023
Address
1-9-7, Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO CORPORATION
Institute
Department
Personal name
Funding Source
Organization
KANEKA 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
Ethical Committee of Nihonbashi Cardiology Clinic
Address
13-4, Nihonbashi Kodenmacho, Chuo-ku, Tokyo, Japan
Tel
03-5641-4133
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
一般財団法人船員保険会 品川シーズンテラス健診クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 23 | 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
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 11 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 04 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 24 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044756
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