UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017866 |
|---|---|
| Receipt number | R000020693 |
| Scientific Title | Study of effect of foods containing lemon polyphenol on reducing body fat |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/01/30 18:35:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of effect of foods containing lemon polyphenol on reducing body fat
Acronym
A trial for reducing body fat
Scientific Title
Study of effect of foods containing lemon polyphenol on reducing body fat
Scientific Title:Acronym
A trial for reducing body fat
Region
| Japan |
Condition
Condition
No (healthy adults or slightly over weight subjects)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of lemon polyphenol on reducing body fat
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Abdominal fat area
Key secondary outcomes
Abdominal circumference
Body weight
BMI
Total cholesterol
HDL cholesterol
LDL cholesterol
Triglyceride
Free fatty acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of 10 tablets containing lemon polyphenol a day for 12 weeks
(lemon polyphenol 500 mg)
Interventions/Control_2
Ingestion of 7 tablets containing lemon polyphenol and 3 tablets not containing lemon polyphenols a day for 12 weeks (lemon polyphenol 350 mg)
Interventions/Control_3
Ingestion of 5 tablets containing lemon polyphenol and 5 tablets not containing lemon polyphenols a day for 12 weeks (lemon polyphenol 250 mg)
Interventions/Control_4
Ingestion of 10 tablets not containing lemon polyphenol a day for 12 weeks (Placebo)
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) Males and females aged 20 to 64 years old.
(2) Subjects with BMI 23-29.9 kg/m2.
(3) Subjects giving written informed consent.
Key exclusion criteria
(1) Subjects who are on a diet.
(2) Subjects who use medication affecting body fat, obesity and/or lipid metabolism.
(3) Subjects who use supplements and/or functional foods affecting body fat, obesity and/or lipid metabolism.
(4) Subjects with excessive alcohol-drinking behaviors.
(5) Subjects who are under treatment.
(6) Subjects who plan an operation before and after the study period (May to December)
(7) Subjects who have allergic reaction to citrus compounds.
(8) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
(9)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(10)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Yoshikawa |
Organization
POKKA SAPPORO FOOD & BEVERAGE LTD
Division name
Corporate Planning Division
Zip code
Address
YEBISU GARDEN PLACE, 4-20-1 Yebisu, Shibuya-ku, Tokyo
TEL
03-5795-1201
Kazuhiko.yoshikawa@pokkasapporo-fb.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Fukumoto |
Organization
POKKA SAPPORO FOOD & BEVERAGE LTD
Division name
Corporate Planning Division
Zip code
Address
YEBISU GARDEN PLACE, 4-20-1 Yebisu, Shibuya-ku, Tokyo
TEL
03-5795-1201
Homepage URL
shuichi.fukumoto@pokkasapporo-fb.co.jp
Sponsor or person
Institute
POKKA SAPPORO FOOD & BEVERAGE LTD
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
ポッカサッポロフード＆ビバレッジ株式会社 恵比寿本社（東京都）
メディカルスキャニング（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020693
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
