UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on effects of long-term ingestion of beta-cryptoxanthin-rich mandarin orange juice on body fat.
Title of the study (Brief title)	Effects of mandarin orange juice on body fat.
Region	Japan

Condition
Condition	obesity
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of long-tern ingestion of beta-cryptoxanthin-rich mandarin orange juice on suppression of body fat.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visceral fat area
Key secondary outcomes	Body weight,BMI,Waist length,Body fat percentage

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	The subjects ingested the active meal for eight weeks.
Interventions/Control_2	The subjects ingested the placebo meal for eight 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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Healthy male and female between 20 and 70 years old 2) Individuals who can refrain from drinking and eating during the test period 3) Individuals who understand the purpose and contents of the experiment
Key exclusion criteria	1)Individuals taking drugs, supplements and healthy foods which affect the blood lipid metabolism 2)Those who can not stop taking supplements or health foods that may affect lipid metabolism during the test period 3)Subjects who are contracting or treating severe diabetes mellitus,kidney and/or liver diseases 4)Those who have been diagnosed with diabetes 5)Individuals with a chronic diseases 6)Those who can not stop taking a large amount of juice during the test period 7)Pregnant women, or women with intending to become pregnant, and lactating woman 8)Individuals participating or intending to participate in a drug administration test 9)Individuals judged by the doctor to be unsuitable
Target sample size	30

Research contact person
Name of lead principal investigator	Kazunari Tanaka
Organization	Univercity of Nagasaki
Division name	Faculty of Nursing and Nutrition
Address	1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL	095-813-5216
Email	katanaka@sun.ac.jp

Public contact
Name of contact person	Hideki Ito
Organization	Univercity of Nagasaki
Division name	Regional Collaboration Center
Address	1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL	095-813-5500
Homepage URL
Email	katanaka@sun.ac.jp

Sponsor
Institute	University of Nagasaki
Institute
Department

Funding Source
Organization	Nagasak prefecture
Organization
Division
Category of Funding Organization	Local Government
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 01 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2018 Year 01 Month 15 Day
Last modified on	2018 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035117