UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016455
Receipt No. 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 (Ver. 15)

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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
Email 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
Email Matsui.yuji@kao.com

Sponsor
Institute New drug research center, Inc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019111