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Recruitment status Completed
Unique ID issued by UMIN UMIN000011751
Receipt No. 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

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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

Condition prediabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

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

Primary outcomes Glucose, insuline
Key secondary outcomes C-peptide, TNF-a, IL-6, IL-1b, leptin, adiponectin, PAI-1, MCP-1, GLP-1

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

No. of arms 3
Purpose of intervention Prevention
Type of intervention
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

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

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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Agriculture,Forestry and Fisheries Research Council
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

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

URL related to results and publications
Number of participants that the trial has enrolled
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
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 related information

Management information
Registered date
2013 Year 09 Month 13 Day
Last modified on
2015 Year 10 Month 18 Day

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