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 |
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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
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
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
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
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
