UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000015025
Receipt number	R000017482
Scientific Title	A Randomized, Double-blind, Placebo-controlled Study on the Anti-Glycation Effect of Food Containing Pomegranate Extract
Date of disclosure of the study information	2014/09/03
Last modified on	2016/04/04 10:33:42

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Basic information

Public title

A Randomized, Double-blind, Placebo-controlled Study on the Anti-Glycation Effect of Food Containing Pomegranate Extract

Acronym

Anti-Glycation Effect of Food Containing Pomegranate Extract

Scientific Title

A Randomized, Double-blind, Placebo-controlled Study on the Anti-Glycation Effect of Food Containing Pomegranate Extract

Scientific Title:Acronym

Anti-Glycation Effect of Food Containing Pomegranate Extract

Region

Japan

Condition

No (Subjects with high amount of skin AGEs accumulation)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To examine the anti-glycation effect of food containing pomegranate extract on blood and skin

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

HbA1c
Glycoalbumin
(carboxymethyl)lysine (CML)
3-Deoxyglucosone
Pentosidine
Skin AGEs
Skin elasticity
Color difference of skin
Analysis of stains, wrinkles, pores, skin color, hidden stains using VISIA
Horny layer AGEs

Key secondary outcomes

Fasting Plasma Glucose
Insulin
Anti-aging QOL common questionnaire test

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Capsule containing 100mg of pomegranate extract, 1 per serving per day

Interventions/Control_2

Capsule not containing pomegranate extract, 1 per serving per day

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

50 years-old <=

Age-upper limit

65 years-old >=

Gender

Female

Key inclusion criteria

(1)(Healthy) post-menopausal females aged 50 to 65 years old.
(2)Subjects whose skin AGEs accumulation determined by AGEReader is more than 2.0.
(3)Subjects who prefer carbohydrates or sweets.
(4)Subjects whose waist circumference is more than 90 cm.
(5)Subjects giving written informed consent.

Key exclusion criteria

(1)Subjects who use oral medication affecting blood sugar.
(2)Subjects who constantly use supplements and/or functional foods affecting blood sugar.
(3)Smoker.
(4)Subjects who have allergic reaction to pomegranate.
(5)Subjects who can't promise not to drink four or more times a week and more than 2 cups in terms of sake in a day.
(6)Subjects who daily average sleep time is less than 6 hours approximately.
(7)Subjects who are during treatment and/or medication with lifestyle-related diseases related to glycation.
(8)Subjects who are suffering from a disease that requires urgent treatment or are having severe complications.
(9)Subjects who have under treatment or a history of drug addiction and/or alcoholism.
(10)Subjects who are planned to participate in other clinical study.
(11)Subjects who are judged as unsuitable for the study by the investigator for other reason.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Haruhi Sugimura

Organization

C'est la vie Shimbashi Clinic

Division name

Medical office

Zip code

Address

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

TEL

03-5408-8671

Email

h-sugimura@shinkokai.jp

Public contact

Name of contact person

1st name

Middle name

Last name Yoshika Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

Address

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

TEL

03-3452-7733

Homepage URL

Email

yoshi@kso.co.jp

Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name

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)

Ministry of Agriculture, Forestry and Fisheries

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 03 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

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

Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 08 Month 25 Day

Date of IRB

Anticipated trial start date

2014 Year 08 Month 30 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2014 Year 09 Month 02 Day

Last modified on

2016 Year 04 Month 04 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017482

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name