UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011751
Receipt number R000013743
Scientific Title Effects of Apple polyphenols on carbohydrate and lipid metabolism in Human study : A randomized, double-blinded, placebo-controlled trial
Date of disclosure of the study information 2013/09/20
Last modified on 2015/10/18 15:56:17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of Apple polyphenols on carbohydrate and lipid metabolism in Human study : A randomized, double-blinded, placebo-controlled trial

Acronym

Apple polyphenols and anti-diabetes study

Scientific Title

Effects of Apple polyphenols on carbohydrate and lipid metabolism in Human study : A randomized, double-blinded, placebo-controlled trial

Scientific Title:Acronym

Apple polyphenols and anti-diabetes study

Region

Japan


Condition

Condition

prediabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate prediabetes by apple polyphenol in Human study

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Glucose, insuline

Key secondary outcomes

C-peptide, TNF-a, IL-6, IL-1b, leptin, adiponectin, PAI-1, MCP-1, GLP-1


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

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

12 weeks, 4 tablets / day

Placebo group

Interventions/Control_2

12 weeks, 4 tablets / day

AP600mg group

Interventions/Control_3

12 weeks, 4 tablets / day

AP900mg group

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

30 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

fasting blood glucose 100<=130>=

Key exclusion criteria

A person who has regular supplements such as grape seed and tea polyphenols.
A person who has participated in other clinical trials in this study at the start. So far, by ingestion of polyphenol and Apple, who has ever complained of a disorder of the body.
1. A person with a history heart failure, myocardial infarction.
2. Treatment of atrial fibrillation, hypertension, arrhythmia, liver failure, renal failure, cerebrovascular disease, arthritis, diabetes, hyperlipidemia, such as anemia.
3. A person have (food, medicine) and allergy history.
4. Pregnant women, nursing mothers
5. Others, who the investigator has determined to be inappropriate as a target for this study.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshihiko Shoji

Organization

National Institute of Fruit Tree Science, National Agriculture & Food Research

Division name

Research Team for Health Benefits of Fruits

Zip code


Address

2-1, Fujimoto, Tsukuba, Ibaraki, 305-8605, Japan

TEL

0298386470

Email

tshoji@affrc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mitsuhiro Yamada

Organization

Kakegawa city

Division name

Health and Prevention Division

Zip code


Address

9-28, Goshyohara, Kakegwa, Shizuoka

TEL

0537-23-8111

Homepage URL


Email

m-yamada@city.kakegawa.shizuoka.jp


Sponsor or person

Institute

National Institute of Fruit Tree Science, National Agriculture & Food Research

Institute

Department

Personal name



Funding Source

Organization

Agriculture,Forestry and Fisheries Research Council

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

掛川市徳育保健センター
農研機構 果樹研究所


Other administrative information

Date of disclosure of the study information

2013 Year 09 Month 20 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

2013 Year 07 Month 26 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date

2013 Year 12 Month 15 Day

Date of closure to data entry


Date trial data considered complete

2014 Year 02 Month 28 Day

Date analysis concluded

2014 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 09 Month 13 Day

Last modified on

2015 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013743


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name