UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016455 |
|---|---|
| Receipt number | R000019111 |
| Scientific Title | A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the beverage containing plant extract (Ex.no.14154) |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2020/03/23 16:34:22 |
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Basic information
Public title
A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the beverage containing plant extract (Ex.no.14154)
Acronym
A clinical trial to investigate the effect of the beverage containing plant extract
Scientific Title
A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the beverage containing plant extract (Ex.no.14154)
Scientific Title:Acronym
A clinical trial to investigate the effect of the beverage containing plant extract
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect on obesity of 12 weeks ingestion of the beverage containing plant extract
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Visceral fat area before intake ,at 8, 12 weeks after intake
Key secondary outcomes
Total fat area, subcutaneous fat area, body weight, BMI, body fat ratio, waist size measurement, hip size measurement, skinfold thickness measurement
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
Food containing plant extract
for 12 weeks
Interventions/Control_2
Food without plant extract
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
Healthy males and females equal to or more than 25kg/m^2 and less than 30kg/m^2 of BMI
Key exclusion criteria
1)Subjects with a history of allergy to medicine and food
2)Subjects who have serious historical disease or have marked impairment of heart, lung,liver, kidney, heart, or gastrointestinal tract functions (excluding extirpation of vermiform appendix). Subjects who have above one relevance to the following conditions
1.TG is above 400 mg/dL
2.total-cholesterol is above 300 mg/dL
3.Fast Blood Glucose is above 126 mg/dL and HbA1c(NGSP)is above 6.5 %
4.AST(GOT)is above 100 U/L
5.ALT(GPT)is above 100 U/L
6.gamma-GTP is above 200 U/L
7.Hemoglobin is below 11.9 g/dL(male), 10.9 g/dL(female)
8.Creatinine is below 1.30 mg/dL(male), 1.00 mg/dL(female)
9.Subjects who don't empty the bowels more than 3 days, or who feel a sense of incomplete evacuation even if who empty the bowels every day
3)Subjects who donated 400 mL of blood within 12 weeks before starting of administration, or who donated 200 mL of blood within 4 weeks or donated blood component within 2 weeks
4)Subjects with systolic blood pressure under 90 mmHg
5)Subjects who smoke excessively and drink alcohol habitually
6)Subjects whose eating habits are extremely irregular or who are midnight and irregular shift workers
7)Subjects who regularly use medicine (depressor drugs, hypolipidemic agents, hypoglycemic drugs, polyene phosphatidylcholine, linoleic acid derivatives, clofibrate, nicomol, unsaponified soybean oil, elastase, artoron, probucol, cholestyramine, HMG-CoA reductase inhibitor, anorexiant drug, etc.), Food for Specified Health Uses, special health-promoting foods known to alter this trial.
8)Subjects who plan to become pregnant, who are during pregnancy, or who are nursing
9)Subjects who participate in other clinical trials or whose participation finishes within 4 weeks prior to the current clinical trial
10)Subjects who are ineligible due to physician's judgment
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo,131-8501 , JAPAN
TEL
+81-3-5630-7268
hibi.masanobu@kao.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Matsui |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo,131-8501 , JAPAN
TEL
+81-3-5630-7268
Homepage URL
Matsui.yuji@kao.com
Sponsor or person
Institute
New drug research center, Inc.
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Miyawaki Orthopedic Clinic
Address
3-1-6, Ariakechou, Eniwa-city,Hokkaido, Japan
Tel
0123-33-4026
s-tomita@ndrcenter.co.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
http://www.pieronline.jp/content/article/0386-3603/44070/1013
Number of participants that the trial has enrolled
150
Results
There was a significant difference in primary outcome
Results date posted
| 2020 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
overweight
Participant flow
144 participants completed and 136 subjects were incorporated into the analyses
Adverse events
No adverse effect related to the test diets reported
Outcome measures
visceral fat area
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 06 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 05 | Day |
Last modified on
| 2020 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019111
