UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Randomized, Double-blind, Placebo-controlled Study on the Anti-Obesity Effect of Food Containing Rosehip Extract
Title of the study (Brief title)	The Anti-Obesity Effect of Food Containing Rosehip Extract
Region	Japan

Condition
Condition	No (Subjects whose BMI are 25 to 30)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the anti-obesity effect of food containing rosehip extract on body fat
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal fat area Body fat percent
Key secondary outcomes	Weight BMI Blood pressure Heart rate Waist circumference Hip circumference Skinfold thickness

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	Treatment
Type of intervention	Food
Interventions/Control_1	Tablet containing 100mg of rosehip extract, 1 per serving per day for 12 weeks
Interventions/Control_2	Tablet not containing rosehip extract, 1 per serving per day 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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Adult subjects whose BMI are 25 to 30 (2)Subjects giving written informed consent
Key exclusion criteria	(1)Subjects who have allergic reaction to medicine. (2)Subjects who smoke excessively and drink alcohol habitually, and whose eating habits are extremely irregular. (3)Subjects who has liver dysfunction or renal dysfunction. (4)Subjects who has history of surgery on gastrointestinal part such as gastrectomy, gastrointestinal suture, and intestinal resection. (5)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. (6)Midnight and irregular shift worker. (7)Subjects who are during pregnancy, nursing, and who plan to become pregnant within six months. (8)Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	32

Research contact person
Name of lead principal investigator	Ikuo Fukuhara
Organization	Fukuhara clinic
Division name	Medical office
Address	3-1-15 Shimamatsuhigashimachi, Eniwashi, Hokkaido
TEL	0123-36-8029
Email	i-feniwa@gray.plala.or.jp

Public contact
Name of contact person	Akifumi Nagatomo
Organization	Morishita Jintan Co.,Ltd.
Division name	Research and Development Division
Address	Osaka Techno Center, 2-11-1, Tsudayamate, Hirakata, Osaka
TEL	072-800-1044
Homepage URL
Email	a-nagatomo@jintan.co.jp

Sponsor
Institute	Morishita Jintan Co.,Ltd.
Institute
Department

Funding Source
Organization	Morishita Jintan Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2014 Year 11 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 04 Day
Anticipated trial start date	2011 Year 09 Month 15 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	Published
URL releasing results	https://doi.org/10.2147/DMSO.S78623
Results
Other related information

Management information
Registered date	2014 Year 11 Month 26 Day
Last modified on	2019 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018341