UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of effect of foods containing lemon polyphenol on reducing body fat
Title of the study (Brief title)	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	Kazuhiko Yoshikawa
Organization	POKKA SAPPORO FOOD & BEVERAGE LTD
Division name	Corporate Planning Division
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	Shuichi Fukumoto
Organization	POKKA SAPPORO FOOD & BEVERAGE LTD
Division name	Corporate Planning Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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