UMIN-CTR Clinical Trial

Public title

Effect of supplement containing dihydroquercetin on Insulin Resistance in Obesity -A randomized, double-blind, and parallel group study-

Acronym

Effect of supplement containing dihydroquercetin on Insulin Resistance

Scientific Title

Effect of supplement containing dihydroquercetin on Insulin Resistance in Obesity -A randomized, double-blind, and parallel group study-

Scientific Title:Acronym

Effect of supplement containing dihydroquercetin on Insulin Resistance

Region

Japan

Condition

Healty volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effect of supplement containing dihydroquercetin on Insulin Resistance in Obese Japanese men

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

ISI(Matsuda Index)

Key secondary outcomes

HOMA-R, HOMA-beta, glucose, insulin, AUC of glucose and insulin, QUICKI

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Ingestion of supplement containing dihydroquercetin for 12 weeks

Interventions/Control_2

Ingestion of placebo without dihydroquercetin 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

Age-lower limit

30

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male

Key inclusion criteria

1)Japanese males aged 30 to 64 years old.
2)Subjects whose BMI are from 25 to 40 kg/m2
3)Subjects whose HOMA-R are higher than 1.6 and ISI level is low.
4)Subjects who can make self-judgment and are voluntarily giving written informed consent

Key exclusion criteria

1)Subjects who use oral medication affecting blood glucose.
2)Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Food with function claims) affecting blood glucose.
3)Subjects who have declared allergic reaction to ingredients contained in test diets.
4) Subjects who are diabetes (including those who are treated with insulin administration)
5)Subjects who contract or are under treatment or are medical history for serious diseases (e.g.,liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder.
6)Subjects who have a chronic disease and use medicines continuously.
7)Subjects who have a history of digestive disease affecting digestion and absorption.
8) Subjects whose fasting blood glucose are above 140 mg/dl.
9)Subjects who are judged as unsuitable for the study based on the results of blood tests by the investigator.
10)Subjects who have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study.
11)Subjects who are diagnosed as anemic and not suitable for frequent collection of blood.
12)Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
13)Subjects who are planning to participate in other clinical studies.
14)Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Haruhi Sugimura

Organization

Medical Corporation Shinkokai C'est La Vie Shinbashi Clinic

Division name

Medical office

Zip code

Address

2-39-3 Nisishimbashi,Minato-ku,Tokyo

TEL

03-5408-8671

Email

h-sughimura@shinkokai.jp

Name of contact person

1st name
Middle name
Last name	Eiji Yoshikawa

Organization

KSO Corporation

Division name

Sales department

Zip code

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL

Email

yoshikawa@kso.co.jp

Institute

KSO Corporation

Institute

Department

Personal name

Organization

FANCL CORPORATION

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

07

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

07

Month

09

Day

Date of IRB

Anticipated trial start date

2015

Year

07

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

07

Month

24

Day

Last modified on

2016

Year

01

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021314