UMIN-CTR Clinical Trial

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
Email	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
Email	yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute	University of Miyazaki
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035178