UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research on the improving effect of the glucose metabolism and vascular endothelial function by piceatannol
Title of the study (Brief title)	Piceatannol 2
Region	Japan

Condition
Condition	Healthy subject and healthy subject with obesity
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify whether oral treatment with piceatannol improve glucose/lipid metabolism and vascular endothelial function,or exert the effects of SIRT1 overexpression/activation and anti-fatigue, and also whether difference of the effect of piceatannol exists between healthy subjects and obesity subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	* Glucose metabolism: blood glucose, insulin, HbA1c, glycated-albumin * Endothelial function: FMD, ADMA, high sensitivity-CRP
Key secondary outcomes	* Body weight, BMI, amount of body fat, % of body fat, skeletal muscle mass, visceral fat area, (In body) * Changing of the expression and activity of SIRT1 and AMPK on isolated peripheral blood mononuclear cells * Lipid metabolism: TC, HDL-C, TG, LDL-C, FFA * Inflammation: IL-6 * Fatigue: d-ROM, BAP, VAS test (Japan Society of fatigue Science, supervision) * Metabolites of piceatannol in blood and urine * Urinary albumin and creatinine * POMS(Mood profile test, questionnaire method) * Safety of throughout the entire study period

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Piceatannol(Group) Taking 4cap/day, twice a day before 30min of breakfast and dinner Taking piceatannol during 2months
Interventions/Control_2	Placebo(Group) Taking 4cap/day, twice a day before 30min of breakfast and dinner Taking piceatannol during 2months
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)Group of Healthy subjects(>=20years old and <70years old): BMI >=18.5 and <25, individuals who have no abnormalities on glucose tolerance, lipid profile and liver function, which are referred by the results of medical examination within one year (When there is no medical examination result within one year, subject needs to take the blood sampling inspection.) (2)Group of healthy subjects with obesity(>=20years old and <70years old): BMI>=25 or visceral fat area>=100cm2, and individuals who have no medication. (3)Individual who has the ability of consent and can sign a written informed consent
Key exclusion criteria	(1)Women who are pregnant, or possibility of pregnant, or wish to pregnant, or lactating. (2)Individual who has a smoking habit. (3)Individual who has a history of allergy to piceatannol (4)Individual who has a food allergy. (5)Participants who are considered unsuitable for inclusion by the attending physician.
Target sample size	40

Research contact person
Name of lead principal investigator	Daisuke Koya
Organization	Kanazawa Medical University
Division name	Daibetology & Endocrinology
Address	1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa, 920-0293
TEL	076-286-2211
Email	koya0516@kanazawa-med.ac.jp

Public contact
Name of contact person	Yuka Kuroshima
Organization	Kanazawa Medical University
Division name	Daibetology & Endocrinology
Address	1-1 Daigaku, Uchinada, Kahoku-gun, Ishikawa, 920-0293
TEL	076-286-2211
Homepage URL
Email	naipicrc@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University
Institute
Department

Funding Source
Organization	MORINAGA & CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	金沢医科大学病院/Kanazawa Medical University Hospital.

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 25 Day
Anticipated trial start date	2015 Year 06 Month 29 Day
Last follow-up date	2017 Year 07 Month 31 Day
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
Results
Other related information

Management information
Registered date	2015 Year 07 Month 23 Day
Last modified on	2018 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021300