UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of cam cam peel extract on energy metabolism and vascular function
Title of the study (Brief title)	Cam cam peel extract functional test
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate energy metabolism and vascular function when taking CamCam peel extract and examine its functionality
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Metabolism and vascular function during exercise 3 hours after ingestion
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	single-dose the Camu-camu (Myrciaria dubia) Pericarp Extract
Interventions/Control_2	long term-dose the Camu-camu (Myrciaria dubia) Pericarp Extract
Interventions/Control_3	single-dose the water
Interventions/Control_4	long term-dose the water
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	30 years-old >=
Gender	Male and Female
Key inclusion criteria	healthy subject
Key exclusion criteria	Circulatory disease
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuhiro Minami
Organization	Tokyo University of Agriculture
Division name	Department of Food and Cosmetic Science, Faculty of Bioindustry
Address	196 Yasaka, Abashiri
TEL	0152-48-3869
Email	k1minami@bioindustry.nodai.ac.jp

Public contact
Name of contact person	Kazuhiro Minami
Organization	Tokyo University of Agriculture
Division name	Department of Food and Cosmetic Science, Faculty of Bioindustry
Address	196 Yasaka, Abashiri
TEL	0152-48-3869
Homepage URL
Email	k1minami@bioindustry.nodai.ac.jp

Sponsor
Institute	Tokyo University of Agriculture
Institute
Department

Funding Source
Organization	Tokyo University of Agriculture
Organization
Division
Category of Funding Organization	Other
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	2017 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 17 Day
Anticipated trial start date	2017 Year 10 Month 17 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	2017 Year 10 Month 07 Day
Last modified on	2017 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033297