UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036318 |
|---|---|
| Receipt number | R000041190 |
| Scientific Title | Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on overweight |
| Date of disclosure of the study information | 2019/03/28 |
| Last modified on | 2022/03/31 00:36:50 |
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Basic information
Public title
Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on overweight
Acronym
Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on overweight
Scientific Title
Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on overweight
Scientific Title:Acronym
Effect of plant-derived lactic acid bacterium-fermented fruit juice powder on overweight
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of plant-derived lactic acid bacterium (Lactobacillus paracasei IJH-SONE68)-fermented fruit juice powder on visceral fat and body weight in subjects with overweight.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes from baseline of mean visceral fat area measured at every 4 weeks interval until week 12.
Key secondary outcomes
Changes from baseline in following parameters:
intestinal flora, BMI, body fat percentage, waist circumference, blood glucose, TG, T-Cho, HDL-C, LDL-C, AST, ALT, and gamma-GTP.
These are also measured at every 4 weeks interval until week 12 (except for intestinal flora, which is measured at week 0 and 12).
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
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects receive 4 capsules (1000 mg) / day containing IJH-SONE68-fermented pineapple juice powder (sterilized) for 12 weeks.
Interventions/Control_2
Subjects receive 4 placebo capsules (1000 mg) / day containing dextrin powder 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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
25<=BMI<30
Key exclusion criteria
1) Allergy to pineapple
2) Taking drugs for chronic disease
3) In pregnancy or nursing a child
4) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia
5) Taking functional food that may affect the body fat percentage and visceral fat
6) Participation in any clinical trial within 90 days of the commencement of the trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Noda |
Organization
Hiroshima University, Graduate School of Biomedical & Health Sciences
Division name
Probiotic Science for Preventive Medicine
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
TEL
082-257-5288
bel@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Noda |
Organization
Hiroshima University, Graduate School of Biomedical & Health Sciences
Division name
Probiotic Science for Preventive Medicine
Zip code
734-8553
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
TEL
082-257-5288
Homepage URL
bel@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Asahi Kohsan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Hiroshima University
Address
Kasumi 1-2-3, Minami-ku, Hiroshima 734-8553, Japan
Tel
082-257-5805
kasumi-kenkyu@office.hiroshima-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
広島大学病院 (広島県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 28 | 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
80
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
| 2019 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
80 participants were already entered.
Management information
Registered date
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2022 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041190
