UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033070 |
|---|---|
| Receipt number | R000037708 |
| Scientific Title | Effect of daily consumption of blueberry leaf extract on visceral fat area (VFA) for 12 weeks :A randomized, double-blind, placebo-controlled comparison group study. |
| Date of disclosure of the study information | 2018/06/21 |
| Last modified on | 2020/09/30 22:34:03 |
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Basic information
Public title
Effect of daily consumption of blueberry leaf extract on visceral fat area (VFA) for 12 weeks :A randomized, double-blind, placebo-controlled comparison group study.
Acronym
Clinical trial to investigate the effect of blueberry leaf extract on VFA reduction.
Scientific Title
Effect of daily consumption of blueberry leaf extract on visceral fat area (VFA) for 12 weeks :A randomized, double-blind, placebo-controlled comparison group study.
Scientific Title:Acronym
Clinical trial to investigate the effect of blueberry leaf extract on VFA reduction.
Region
| Japan |
Condition
Condition
Adults whose BMI is >= 23 kg/ m2 ,<30 kg/m2
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of blueberry leaf extract on VFA reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
VFA at baseline, after 4 weeks, 8 weeks, 12 weeks and 16 weeks of intervention with test food or placebo food.
Key secondary outcomes
1.Waist circumference
2.BMI, Body weight
3.The actual values and the change from pre-ingestion of glycolipid metabolism related index at each evaluation point (Adiponectin, Triglyceride, HDL-C, LDL-C, insulin, glucose).
4.The amount of activity (Step count, amount of exercise(EX))
5. The actual values and the change from pre-ingestion of blood index at each evaluation point except 3.
6.Adverse events
(They are assessed at baseline, after 4 weeks, 8 weeks, 12 weeks and 16 weeks of intervention with test food or placebo food except adverse events.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects take test food (including blueberry extract) 3 tablets once day for 12 weeks.
Interventions/Control_2
The subjects take placebo food (not including blueberry extract) 3 tablets once day 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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects whose BMI is >= 23 kg/ m2 ,<30 kg/m2
2. Subjects who have no abnormality in clinical problems by screening tests.
3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects who have serious respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases.
2. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
3. Pre- or post-menopausal women having obvious changes in physical condition.
4. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction.
5. Heavy drinkers (drink more than 80 g of alcohol per day), subjects who are dependent on alcohol or drugs, possible alcohol or drug abusers.
6. Subjects who regularly take drugs (anti-dyslipidemia,anti-diabetes etc.), which would affect this study.
7. Subjects who regularly take foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
8. Subjects who donate either 400 ml whole blood within, 200 ml whole blood or blood components within 4 weeks prior to this study.
9. Pregnant or lactating women or women expect to be pregnant during this study.
10. Subjects who have cognitive disorder or who have possibility of the disorder.
11. Subjects who participate and take the study drug in other clinical trials within 4 weeks prior to this study.
12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Clinical research support center, university of Miyazaki hospital
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Clinical research support center, university of Miyazaki hospital
Zip code
889-1692
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Miyazaki Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 21 | 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
| 2018 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 11 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 20 | Day |
Last modified on
| 2020 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037708
