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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017866
Receipt No. 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

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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
Email 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
Email shuichi.fukumoto@pokkasapporo-fb.co.jp

Sponsor
Institute POKKA SAPPORO FOOD & BEVERAGE LTD
Institute
Department

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
Email

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
URL(English) https://upload.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


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