UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030838 |
|---|---|
| Receipt number | R000035178 |
| Scientific Title | A randomized double-blind, placebo-controlled crossover study to investigate the suppressive effect of blueberry leaf extract on the postprandial triglyceride level elevation. |
| Date of disclosure of the study information | 2018/01/16 |
| Last modified on | 2022/06/23 23:27:52 |
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Basic information
Public title
A randomized double-blind, placebo-controlled crossover study to investigate the suppressive effect of blueberry leaf extract on the postprandial triglyceride level elevation.
Acronym
The trial for investigation of suppressive effect of blueberry leaf extract on the postprandial triglyceride level elevation.
Scientific Title
A randomized double-blind, placebo-controlled crossover study to investigate the suppressive effect of blueberry leaf extract on the postprandial triglyceride level elevation.
Scientific Title:Acronym
The trial for investigation of suppressive effect of blueberry leaf extract on the postprandial triglyceride level elevation.
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the suppressive effect of blueberry leaf extract on the postprandial triglyceride level elevation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Incremental area under the curve (IAUC) of postprandial triglyceride level
Key secondary outcomes
1.The actual values and the changes of postprandial triglycerides at each evaluation point (1,2,3,4 and 5 hours)after meal load.
2.The increment of postprandial triglyceride level.
3.The actual values and the changes of glycolipid metabolism related index at each evaluation point after meal load.
4.Adverse events.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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 100 ml test food containing blueberry extract before meal load.
Interventions/Control_2
The subjects take 100 ml placebo food not containing blueberry extract before meal load.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who have above 100mg/dL and less than 199mg/dl of fasting triglyceride level.
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. Subjects who are heavy alcohol addicts (more than 80 g per day alcohol), or alcohol or drug dependency or who have possibility of the dependency.
6. Subjects who regularly take drugs, 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 200 ml whole blood, 400 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
20
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
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 | 01 | Month | 16 | Day |
Related information
URL releasing protocol
No public announcement
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000035178
Number of participants that the trial has enrolled
15
Results
The primary endpoint, IAUC of postprandial triglyceride levels, showed a trend toward a decrease with the blueberry leaf extract-containing (BLE) drink, but there was no statistical difference. However, the secondary endpoints of postprandial triglyceride, RLP-C, and ApoB48 were significantly lower in the BLE drink, suggesting that the blueberry leaf extract-containing drink suppressed postprandial triglyceride absorption (Reported in Clinical study report Version 1 on July 23, 2019).
Results date posted
| 2022 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 07 | Month | 23 | Day |
Baseline Characteristics
Fifteen eligible study participants were randomly assigned to two groups (blueberry leaf extract-containing drink prior group or placebo drink prior group) by stratified randomization using age, gender, and fasting triglyceride levels as allocation factors. Of the 15 eligible study participants, 7 were male and 8 were female. There were no significant differences between the two groups in blood pressure, peripheral blood tests, liver function, renal function, or lipid tests at the time of the screening test. Only fasting plasma glucose differed between the two groups, being significantly higher in the placebo drink prior group, but not in HbA1c. There were also no significant differences in visceral fat area or abdominal circumference.
Participant flow
Eight patients were assigned to the blueberry leaf extract-containing drink prior group and seven to the placebo drink prior group, for a total of 11 patients (7 and 4, respectively) who completed the study.
Adverse events
Four of 15 participants (26.7%) had a total of 5 adverse events, none of which were serious adverse events. 3 of the 4 participants discontinued the study.
Outcome measures
Primary endpoint: Incremental area under the curve (IAUC) of postprandial triglyceride level; secondary endpoints: 1. The actual values and the changes of postprandial triglycerides at each evaluation point (1,2,3,4, and 5 hours) after meal load; 2. Maximum increase in postprandial triglycerides; 3. The actual values and the changes of glycolipid metabolism related index (RLP-C, ApoB48, HDL-C, LDL-C, leptin, insulin, ghrelin, and glucose) at each evaluation point after meal load; and 4. Adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 24 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 28 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035178
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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