UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034285 |
|---|---|
| Receipt number | R000039086 |
| Scientific Title | A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of visceral fat and body fat - Randomized placebo-controlled double-blind parallel group comparison study- |
| Date of disclosure of the study information | 2020/05/24 |
| Last modified on | 2020/03/26 10:21:52 |
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Basic information
Public title
A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of visceral fat and body fat
- Randomized placebo-controlled double-blind parallel group comparison study-
Acronym
A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of visceral fat and body fat
Scientific Title
A study to evaluate the effects of foods containing plant-derived ingredients on the reduction of visceral fat and body fat
- 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 the reduction of visceral fat and body fat
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for reduction of visceral fat / body fat and for safety when supplementation with food containing ingredients of plant origin for 12 weeks for healthy adult men and women with BMI of 23.0 or more and less than 30.0 kg/m2
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal visceral fat area, body fat mass
Key secondary outcomes
Abdominal subcutaneous fat area, abdominal total fat area, waist circumference, hip circumference, W/H ratio, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglyceride, blood pressures (systolic and diastolic), fasting blood glucose, insulin, 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.
2)Subjects whose BMI values are 23.0 or more and less than 30.0.
3)Subjects who can visit the hospital/clinic on the scheduled visit date
4)Subjects who agreed in writing prior to the start of the trial with sufficient understanding of the purpose and contents of this study
Key exclusion criteria
1)Subjects who are under treatment or have a history of serious liver damage/disease, kidney disease, heart disease, lung disease, gastrointestinal disease (including gastrectomy), other severe disorders, or diabetes
2)Subjects who are under treatment (Excluding transient treatment such as common cold)
3)Subjects who cannot maintain their own life-style
4)Subjects who plan to travel overseas or have a long business trip during this study period
5)Subjects who are shift workers or graveyard shift workers
6)Subjects who use oral medication or supplements which may affect this study
7)Subjects drink alcohol over 1,000mL in terms of beer (= 40 mL of pure alcohol) per day
8)Subjects smoke over average 20 cigarettes per day
9)Subjects who are pregnant, lactation, or planning to become pregnant
10)Subjects who are sensitive to test product or other foods, and medical products.
11)Subjects who cannot take the test food as instructed
12)Subjects who donated blood component or more than 200 mL of whole blood from the last one month just before the start of the study
13)Subjects who have experienced sickness due to blood collection
14)Subjects in constipation (frequency of defecation twice or less a week, feces is hard, difficulty of defecation, feeling of remaining feces)
15)Subjects who participated in other clinical studies in the past 3 months
16)Subjects who have some metal inside the body
17)Subjects judged as unsuitable for this study by the principal investigator
Target sample size
180
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 | Soichi |
| Middle name | |
| Last name | Yoneda |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Food Test Division
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo,
TEL
03-6386-8809
Homepage URL
s-yoneda@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
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
Kanazawabunko Hospital,IRB
Address
2-6-22,Kamariyahigashi,Kanazawaku,Ykohamashi,Kanagawa,Japan
Tel
045-785-3311
watanabe@kanabun-hp.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
金内メディカルクリニック（東京都）、上尾中央第二病院（埼玉県）、笛吹中央病院（山梨県）、武蔵境クリニック（東京都）、久野マインズタワークリニック（東京都）、戸田中央総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 24 | 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
200
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
| 2018 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 06 | 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
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039086
